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101 results on '"Jain, Minish"'

1. A Randomized, Double-Blind, Phase III Study in India for Comparing Efficacy, Safety, and PK of ZRC-3277 (Pertuzumab Biosimilar) With Perjeta® in Patients With HER2-Positive Metastatic Breast Cancer

Author

Kothari, Rushabh, Doshi, Maulik, Chaithanya, P.K., CT, Satheesh, Kumar, Anil, Mallavarapu, Krishna Mohan, Nagarkar, Rajnish, Mahobia, Vijay, Bhatt, Niraj, Priyadarshini, K.L., Gogia, Ajay, Maksud, Tanveer, Prasad, Saurabh, Velavan, K., L․K․, Rajeev, SS, Prakash, Talreja, Vikas, Kalra, Kaushal, Nemade, Bhushan, Dastidar, Aloke Ghosh, Gupta, Tarachand, Patil, Tushar, Bondarde, Shailesh, Patel, Pinakin, Gupta, Sudeep, Biswas, Ghanashyam, Vaghela, Manan, Mahato, Pinaki, Parekh, Honey, Kalloli, Mahesh, Shetty, Rachan, Prakash, Gaurav, Goel, Anil, Mandal, Srikrishna, Choudhury, Tamohan, Jain, Minish, Goswami, Chanchal, H․M․, Yathish Kumar, Mukherjee, K․K․, Shrivastava, Rahul, and Parmar, Deven

Published
2024
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2. Rituximab biosimilar for the treatment of diffuse large B-cell lymphoma: a phase 3 randomized study in India

Author

Patel, Ankit, Bhatt, Niraj, Prakash, S. S., Biswas, Ghanashyam, Nagarkar, Rajnish, Roy, Bodhisatta, Samal, Priyanka, Agrawal, Narendra, Meshram, Sushil, Kaushal, Ashish, Satheesh, C. T., Wategaonkar, Ravikumar, Thiagarajan, Kasi Viswanathan, Jain, Kartikeya, Vijayaveeran, P., Mukherjee , Kalyan, Singh, Kishore, Patil, Tushar, Jain, Amit, Dolai, Tuphan Kanti, Jain, Minish, Hingmire, Sachin, Gupta, Tara Chand, Lakshmaiah, K. C., Rajamanickam, Deepan, Nemade, Bhushan, Goyal, Vikash, Mahato, Pinaki, Mendiratta, Sanjeev Kumar, and Doshi, Maulik

Published
2023
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3. Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial

Author

Hickish, Tamas, Mehta, Ajay, Liu, Mei-Ching, Huang, Chiun-Sheng, Arora, Rajendra Singh, Chang, Yuan-Ching, Yang, Youngsen, Vladimirov, Vladimir, Jain, Minish, Tsang, Janice, Pemberton, Karine, Sadrolhefazi, Behbood, Jin, Xidong, and Tseng, Ling-Ming

Published
2022
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4. Daratumumab in Indian patients with relapsed and refractory multiple myeloma: a prospective, multicenter, phase IV study.

Author

Kumar, Lalit, Melinkeri, Sameer, Ganesan, Prasanth, Kumar, Jeevan, Biswas, Ghanashyam, Kilara, Nalini, Pathalingappa, Harish, Prasad, SVSS, Jain, Minish, Mishra, Sourav Kumar, Prasad, Saurabh, Boyella, Pavan Kumar, Sahoo, Ranjit Kumar, Bondarde, Shailesh, Shah, Sandip, Rege, Milind, Deb, Uttiya, Korde, Tanuja, and Dixit, Jitendra

Abstract

Aim: To assess the safety and effectiveness of daratumumab monotherapy in Indian patients with relapsed/refractory multiple myeloma. Methods: In this prospective, multicenter, phase IV study, patients (aged ≥18 years) received intravenous daratumumab (16 mg/kg) in six cycles. Safety was the primary end point. Results: Of the 139 patients included, 121 (87.1%) experienced ≥1 treatment-emergent adverse events (TEAEs; 53 [38.1%] drug-related), 32 (23%) had ≥1 serious TEAEs (five [3.6%] drug-related) and 16 (11.5%) deaths were reported (one death [0.7%] was drug-related). Overall response rate was 26.3%; 62.7% of patients had stable disease. Median time to first response and median progression-free survival were 5.2 and 5.9 months, respectively. Functional status and well-being were improved. Conclusion: Daratumumab showed an acceptable and expected safety profile with consistent efficacy, providing a novel therapeutic option for relapsed/refractory multiple myeloma management in India. Daratumumab is a monoclonal antibody approved for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). This study evaluated the outcome of daratumumab single therapy in Indian patients who were not cured with other drugs used for the same disease. 139 adult patients were included in this study from 15 institutes across India. Daratumumab (16 mg/kg) was diluted with 500 or 1000 ml of saline solution and given slowly through the intravenous route 16-times within 6 months. The study examined whether the safety profile and benefits of daratumumab reported in Indian patients were similar to those reported in the RRMM populations of other countries. The study found that most of the adverse events were not severe and could be easily treated by the study physician. 16 patients died (one might have been due to daratumumab treatment). Daratumumab treatment provided life support and recovery benefits to many patients. Daratumumab single therapy provides an appropriate and acceptable safety profile with no new adverse events and consistent benefits in RRMM patients. Clinical Trial Registration:NCT03768960 (ClinicalTrials.gov), CTRI/2019/06/019546. This study demonstrated an acceptable and expected safety profile with consistent efficacy for daratumumab monotherapy in patients with relapsed/refractory multiple myeloma, providing a novel therapeutic option for myeloma management in India. [ABSTRACT FROM AUTHOR]

Published
2024
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5. P740: PK, PD AND SAFETY OF FIRST-IN-HUMAN, FIRST-IN-CLASS PHASE I TRIAL (AUR103-101; BHARAT) OF AUR103, AN ORAL CD47 INHIBITOR, IN PATIENTS WITH ADVANCED MALIGNANCIES

Author

Krishnappa, Manjunath, primary, Mandavia, Divyesh, additional, Jain, Minish, additional, S, Mukesh, additional, Patel, Ankit, additional, Agarwal, Anshul, additional, Giri, Sanjeev, additional, Kumar Tiwari, Nirbhay, additional, Thiyagarajan, Saravanan, additional, Dey, Mamon, additional, Padmanabha Naidu, Gutta, additional, Ramachandra, Murali, additional, and Kumar, Akhil, additional

Published
2023
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6. Gonadotropin-releasing hormone agonists in prostate cancer: A comparative review of efficacy and safety

Author

Raja, T., Sud, Rahul, Addla, Sanjai, Sarkar, Kalyan, Sridhar, P., Talreja, Vikas, Jain, Minish, and Patil, Ketaki

Subjects
Prostate cancer -- Drug therapy, Gonadotropin -- Comparative analysis, Pituitary hormones -- Comparative analysis, Testosterone -- Comparative analysis, Health, Zoladex (Medication) -- Comparative analysis
Abstract

Byline: T. Raja, Rahul. Sud, Sanjai. Addla, Kalyan. Sarkar, P. Sridhar, Vikas. Talreja, Minish. Jain, Ketaki. Patil Androgen deprivation therapy (ADT) using gonadotropin-releasing hormone agonist (s) (GnRH-A) remains the backbone [...]

Published
2022

8. Mesenteric leiomyosarcoma in a pregnant woman: A case report and review of literature

Author

Deshmukh, Sanjay, Jain, Minish, and Chharchhodawala, Taher

Subjects
Pregnancy, Ultrasound imaging, Leiomyosarcoma, Chemotherapy, Pregnant women, Anthracyclines, Cancer -- Chemotherapy, Obstetrics, Health
Abstract

Byline: Sanjay. Deshmukh, Minish. Jain, Taher. Chharchhodawala We herein describe a case of primary leiomyosarcoma of descending mesocolon mesentery in a pregnant woman. A 31-year-old woman was referred to our [...]

Published
2021

9. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial

Author

Ignatius Ou, SaiHong, Planchard, David, Park, Keunchil, Schuler, Martin, Yang, James, Chand, Vikram, Rohr, Klaus, Bagnes, Claudia, Martin, Claudio Marcelo, Recondo, Gonzalo, Zarba, Juan Jose, Blajman, Cesar, Richardet, Martín, McLachlan, Sue-Anne, Parente, Phillip, Underhill, Craig, Crombie, Catherine, Mainwaring, Paul, Greil, Richard, Humblet, Yves, Bustin, Frédérique, Carestia, Luciano, Galdermans, Danny, Lambrechts, Marc, Delval, Laetitia, Vercauter, Piet, Zhou, Caicun, Wang, Jin, Huang, Cheng, Lin, Xiaoyan, Wu, Yilong, Liu, Xiaoqing, Cheng, Ying, Qin, Shukui, Feng, Jifeng, Huang, Jianjin, Zhang, Yiping, Lu, Shun, Zereu, Manuela, Garicochea, Bernardo, Zadra, Cyntia Albuquerque, Riska, Henrik, Alanko, Tuomo, Cadranel, Jacques, Chouaid, Christos, Zalcman, Gérard, Sibilot, Denis Moro, Perol, Maurice, Bennouna, Jaafar, Fournel, Pierre, Gervais, Radj, Rotarski, Maciej, Coudert, Bruno, Thomas, Michael, Wehler, Thomas, Faehling, Martin, Keilholz, Ulrich, Laack, Eckart, von Pawel, Joachim, Huber, Rudolf, Dickgreber, Nicolas, Wiewrodt, Rainer, Mark, Zsuzsanna, Tehenes, Sandor, Strausz, Janos, Sarosi, Veronika, Prabhash, Kumar, Jain, Minish, Venkatesan, Srinivasan, Sharma, Lalit, Dadhich, Hemant, Nagarkar, Rajnish Vasant, Onn, Amir, Gottfried, Maya, Stemmer, Solomon, Migliorino, Maria Rita, Grossi, Francesco, Bidoli, Paolo, Bearz, Alessandra, Gridelli, Cesare, Milandri, Carlo, Platania, Marco, Ceresoli, Giovanni Luca, Cruciani, Giorgio, Delgado, Francisco Gutierrez, Gonzalez Perez, José Luis, Luna, Gabriela Alvarado, Baca, Othon Padilla, Aerts, J.G.J.V., Stigt, J.A., Dingemans, A.M.C., Herder, G.J.M., Gans, S.J.M., Salas Sánchez, Jorge Fernando, Alvarez Barreda, Renzo Luzgardo, Pantigoso, Wilbert Rodriguez, Palomino, Osbert Luis Mejia, Jaskiewicz, Piotr, Kazarnowicz, Andrzej, Serwatowski, Piotr, Szczesna, Aleksandra, Jassem, Jacek, Lubennikov, Vladimir, Karaseva, Nina, Orlov, Sergey, Ragulin, Yuri, Garrido, Pilar, González Larriba, José Luis, Camps, Carlos, Campelo, Rosario García, Lianes, Pilar, Cobo, Manuel, Felip, Enriqueta, Kim, Dong-Wan, Kim, Sang-We, Kim, Joo-Hang, Han, Ji-Youn, Kim, Young-Chul, Yang, Chih-Hsin, Hsia, Te-Chun, Chen, Yuh-Min, Tsai, Ying-Huang, Chang, Gee-Chen, Tsao, Thomas Chang-Yao, Su, Wu-Chou, Huang, Ming-Shyan, Ho, Ching-Liang, Hsieh, Ruey-Kuen, Vinnyk, Yuriy, Popovych, Oleksandr, Ponomarova, Olga, Bondarenko, Igor, Polishchuk, Iryna, Shah, Riyaz, Mitra, Sanka, Popat, Sanjaykumar, Spicer, James, Toy, Elizabeth, Talbot, Toby, Brown, Emma, Upadhyay, Sunil, Summers, Yvonne, Gurtler, Jayne, Meza, Luis, Thropay, John, Schuler, M., Yang, J.C.-H., Park, K., Kim, J.-H., Bennouna, J., Chen, Y.-M., Chouaid, C., De Marinis, F., Feng, J.-F., Grossi, F., Kim, D.-W., Liu, X., Lu, S., Strausz, J., Vinnyk, Y., Wiewrodt, R., Zhou, C., Wang, B., Chand, V.K., and Planchard, D.

Published
2016
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12. Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study

Author

Jain, Minish M., Gupte, Smita U., Patil, Shekhar G., Pathak, Anand B., Deshmukh, Chetan D., Bhatt, Niraj, Haritha, Chiramana, Govind Babu, K., Bondarde, Shailesh A., Digumarti, Raghunadharao, Bajpai, Jyoti, Kumar, Ravi, Bakshi, Ashish V., Bhattacharya, Gouri Sankar, Patil, Poonam, Subramanian, Sundaram, Vaid, Ashok K., Desai, Chirag J., Khopade, Ajay, Chimote, Geetanjali, Bapsy, Poonamalle P., and Bhowmik, Shravanti

Published
2016
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13. A Real-World Study of Safety, Immunogenicity and Efficacy of Bevacizumab in Patients With Solid Malignancies: A Phase IV, Post-Marketing Study in India.

Author

Sinha, Shubhadeep D., Biswas, Ghanashyam, Bheemareddy, Bala Reddy, Chary, Sreenivasa, Thakur, Pankaj, Jain, Minish, Maksud, Tanveer, Pawar, Suraj, Chatterjee, Koushik, Voonna, Murali Krishna, Goel, Anil, Puligundla, Krishna Chaitanya, Lakshmaiah, Kuntegowdanahalli Chinnagiriyappa, Talluri, Leela, Vattipalli, Ramya, and Kakkunnath, Sheejith

Subjects
BEVACIZUMAB, IMMUNE response, NON-small-cell lung carcinoma, RENAL cell carcinoma
Abstract

OBJECTIVE: The aim of this study was to evaluate the post-marketing safety, tolerability, immunogenicity and efficacy of Bevacizumab (manufactured by Hetero Biopharma) in a broader population of patients with solid tumors. PATIENTS AND METHODS: This phase IV, prospective, multi-centric clinical study was carried out in Indian patients with solid malignancies (metastatic colorectal cancer, non-squamous non-small-cell lung cancer, metastatic renal cell carcinoma) treated with Bevacizumab between April 2018 and July 2019. This study included 203 patients from 16 tertiary care oncology centers across India for safety assessment, of which a subset of 115 patients who have consented were also evaluated for efficacy and immunogenicity. This study was prospectively registered in the Clinical Trial Registry of India (CTRI), and was commenced only after receiving approval from the competent authority (Central Drugs Standard Control Organization, CDSCO). RESULTS: Out of the 203 enrolled patients, 121 (59.6%) patients reported 338 adverse events (AEs) during this study. Of 338 reported AEs, 14 serious adverse events (SAEs) were reported by 13 patients including 6 fatal SAEs, assessed as unrelated to the study medication and 7 non-fatal SAEs, 5 assessed as related, and 3 unrelated to Bevacizumab. Most AEs reported in this study (33.9%) were general disorders and administration site conditions, followed by gastrointestinal disorders (29.1%). The most frequently reported AEs were diarrhea (11.3%), asthenia (10.3%), headache (8.9%), pain (7.4%), vomiting (7.9%), and neutropenia (5.9%). At the end of the study, 2 (1.75%) of 69 patients reported antibodies to Bevacizumab without affecting safety and efficacy. However, at the end of 12 months, no patient had reported antibodies to Bevacizumab. Complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) were reported in 18.3%, 22.6%, 9.6%, and 8.7% of patients, respectively. The overall response rate (CR + PR) was reported in 40.9% of patients at the end of the study. Disease control rate (DCR), also known as the clinical benefit rate (CBR) was reported in 50.4% of patients. CONCLUSIONS: Bevacizumab (Cizumab, Hetero Biopharma) was observed to be safe, well tolerated, lacking immunogenicity, and efficacious in the treatment of solid tumors. The findings of this phase IV study of Bevacizumab, primarily as a combination therapy regimen suggest its suitability and rationality for usage in multiple solid malignancies. [ABSTRACT FROM AUTHOR]

Published
2023
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16. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial

Author

Schuler, M., Yang, J. C.-H., Park, K., Kim, J.-H., Bennouna, J., Chen, Y.-M., Chouaid, C., De Marinis, F., Feng, J.-F., Grossi, F., Kim, D.-W., Liu, X., Lu, S., Strausz, J., Vinnyk, Y., Wiewrodt, R., Zhou, C., Wang, B., Chand, V. K., Planchard, D., Ignatius Ou, Sai Hong, Planchard, David, Park, Keunchil, Schuler, Martin, Yang, James, Chand, Vikram, Rohr, Klaus, Bagnes, Claudia, Martin, Claudio Marcelo, Recondo, Gonzalo, Zarba, Juan Jose, Blajman, Cesar, Richardet, Martín, McLachlan, Sue-Anne, Parente, Phillip, Underhill, Craig, Crombie, Catherine, Mainwaring, Paul, Greil, Richard, Humblet, Yves, Bustin, Frédérique, Carestia, Luciano, Galdermans, Danny, Lambrechts, Marc, Delval, Laetitia, Vercauter, Piet, Zhou, Caicun, Wang, Jin, Huang, Cheng, Lin, Xiaoyan, Wu, Yilong, Liu, Xiaoqing, Cheng, Ying, Qin, Shukui, Feng, Jifeng, Huang, Jianjin, Zhang, Yiping, Lu, Shun, Zereu, Manuela, Garicochea, Bernardo, Zadra, Cyntia Albuquerque, Riska, Henrik, Alanko, Tuomo, Cadranel, Jacques, Chouaid, Christos, Zalcman, Gérard, Sibilot, Denis Moro, Perol, Maurice, Planchard, David, Bennouna, Jaafar, Fournel, Pierre, Gervais, Radj, Rotarski, Maciej, Coudert, Bruno, Schuler, Martin, Thomas, Michael, Wehler, Thomas, Faehling, Martin, Keilholz, Ulrich, Laack, Eckart, von Pawel, Joachim, Huber, Rudolf, Dickgreber, Nicolas, Wiewrodt, Rainer, Mark, Zsuzsanna, Tehenes, Sandor, Strausz, Janos, Sarosi, Veronika, Prabhash, Kumar, Jain, Minish, Venkatesan, Srinivasan, Sharma, Lalit, Dadhich, Hemant, Nagarkar, Rajnish Vasant, Onn, Amir, Gottfried, Maya, Stemmer, Solomon, Migliorino, Maria Rita, Grossi, Francesco, Bidoli, Paolo, Bearz, Alessandra, Gridelli, Cesare, Milandri, Carlo, Platania, Marco, Ceresoli, Giovanni Luca, Cruciani, Giorgio, Delgado, Francisco Gutierrez, Gonzalez Perez, José Luis, Luna, Gabriela Alvarado, Baca, Othon Padilla, Aerts, J.G.J.V., Stigt, J.A., Dingemans, A.M.C., Herder, G.J.M., Gans, S. J. M., Salas Sánchez, Jorge Fernando, Alvarez Barreda, Renzo Luzgardo, Pantigoso, Wilbert Rodriguez, Palomino, Osbert Luis Mejia, Jaskiewicz, Piotr, Kazarnowicz, Andrzej, Serwatowski, Piotr, Szczesna, Aleksandra, Jassem, Jacek, Lubennikov, Vladimir, Karaseva, Nina, Orlov, Sergey, Ragulin, Yuri, Garrido, Pilar, González Larriba, José Luis, Camps, Carlos, Campelo, Rosario García, Lianes, Pilar, Cobo, Manuel, Felip, Enriqueta, Kim, Dong-Wan, Kim, Sang-We, Park, Keunchil, Kim, Joo-Hang, Han, Ji-Youn, Kim, Young-Chul, Yang, Chih-Hsin, Hsia, Te-Chun, Chen, Yuh-Min, Tsai, Ying-Huang, Chang, Gee-Chen, Tsao, Thomas Chang-Yao, Su, Wu-Chou, Huang, Ming-Shyan, Ho, Ching-Liang, Hsieh, Ruey-Kuen, Vinnyk, Yuriy, Popovych, Oleksandr, Ponomarova, Olga, Bondarenko, Igor, Polishchuk, Iryna, Shah, Riyaz, Mitra, Sanka, Popat, Sanjaykumar, Spicer, James, Toy, Elizabeth, Popat, Sanjaykumar, Talbot, Toby, Brown, Emma, Upadhyay, Sunil, Summers, Yvonne, Gurtler, Jayne, Meza, Luis, and Thropay, John

Published
2016
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17. Comparison of Efficacy and Safety of Lupin’s Pegfilgrastim with Neulastim® as an Adjunct to Chemotherapy in Patients with NonMyeloid Malignancies: A Randomised Phase III Clinical Study.

Author

JAIN, MINISH, DESAI, SHARAD, NAGARKAR, RAJNISH, NEVE, RAKESH, TAKALKAR, UNMESH, BAKHLE, DHANANJAY, and SHAH, CHIRAG

Subjects
*FILGRASTIM, *GRANULOCYTE-colony stimulating factor, *FEBRILE neutropenia, *CANCER chemotherapy, *SUBCUTANEOUS injections
Abstract

Introduction: Pegfilgrastim is indicated in patients receiving myelosuppressive anticancer drugs to reduce the Duration of Severe Neutropenia (DSN) and incidence of Febrile Neutropenia (FN). The efficacy and safety of a proposed pegfilgrastim biosimilar should be compared with an approved biologic drug to establish therapeutic equivalence. Aim: To compare the efficacy of Lupin’s biosimilar Pegfilgrastim versus Neulastim® (Amgen Inc.) as an adjunct to chemotherapy in patients with non-myeloid malignancies. Materials and Methods: The present prospective, open-label, randomised phase lll clinical study was conducted on a total of 170 patients with histologically or cytologically confirmed non-myeloid malignancies eligible to receive a myelosuppressive chemotherapy regimen. The participants were administered Lupin’s Pegfilgrastim (n=86) or Neulastim® (n=84) 6 mg by subcutaneous injection, once in each chemotherapy cycle for a maximum of three cycles. Patients were chemotherapy naive or had not received myelosuppressive chemotherapy within last 12 months of screening. The primary efficacy endpoint was DSN (number of days on which absolute neutrophil count <0.5×109 /L) in cycle 1 of chemotherapy. Equivalence was confirmed if 95% Confidence Intervals (CI) were within the equivalence margin of ±1 day. Safety evaluation included assessment of Adverse Events (AEs), rate of discontinuation due to AEs, vital signs, and laboratory parameters. Statistical analysis were done using SAS Enterprise guide 9.4 (SAS Institute Inc., Cary, 2000). Results: Of the 170 patients balanced for demographic characteristics, 161 patients completed cycle 1, 151 patients completed cycle 2, and 142 patients completed cycle 3. The mean±Standard Deviation (SD) DSN in cycle 1 was 0.127±0.5533 days with Pegfilgrastim (n=63) and 0.197±0.6615 days with Neulastim® (n=66) in the Per Protocol (PP) assessment; and 0.174±0.636 days with Pegfilgrastim and 0.193±0.671 days with Neulastim® in the modified Intent-to-Treat (mITT) assessment. The mean DSN between the groups did not differ significantly (PP: p=0.5167, mITT: p=0.8554). The 95% CI of difference in mean DSN in PP (-0.2796 to 0.1481) and mITT (-0.2103 to 0.1889) assessments was contained within the predefined equivalence margin of ±1 day. Secondary outcomes and safety profiles were also comparable between the two groups. Conclusion: The present study establishes Lupin’s Pegfilgrastim as a therapeutically equivalent biosimilar alternative to Neulastim® in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. [ABSTRACT FROM AUTHOR]

Published
2022
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18. The ACT-ONE trial, a multicentre, randomised, double-blind, placebo-controlled, dose-finding study of the anabolic/catabolic transforming agent, MT-102 in subjects with cachexia related to stage III and IV non-small cell lung cancer and colorectal cancer: study design

Author

Stewart Coats, Andrew J., Srinivasan, Venkatesan, Surendran, Jayaraman, Chiramana, Haritha, Vangipuram, Shankar R. K. G., Bhatt, Nirajkumar N., Jain, Minish, Shah, Sandip, Ali, Irfhan A. B. H., Fuang, Ho G., Hassan, Mohammed Z. M., Beadle, John, Tilson, Julia, Kirwan, Bridget-Anne, Anker, Stefan D., and on behalf of the ACT-ONE Trial Investigators

Published
2011
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20. Afatinib vs placebo as adjuvant therapy after chemoradiotherapy in squamous cell carcinoma of the head and neck : a randomized clinical trial

Author

Burtness, Barbara, Haddad, Robert, Dinis, Jose, Trigo, Jose, Yokota, Tomoya, de Viana, Luciano Souza, Romanov, Ilya, Vermorken, Jan Baptist, Bourhis, Jean, Tahara, Makoto, Martins Segalla, Jose Getulio, Psyrri, Amanda, Vasilevskaya, Irina, Nangia, Chaitali Singh, Chaves-Conde, Manuel, Kiyota, Naomi, Homma, Akihiro, Holeckova, Petra, Del Campo, Josep Maria, Asarawala, Nirav, Nicolau, Ulisses Ribaldo, Rauch, Daniel, Even, Caroline, Wang, Bushi, Gibson, Neil, Ehrnrooth, Eva, Harrington, Kevin, Cohen, Ezra E. W., Eduardo Giglio, Raul, Raul Blajman, Cesar, Mario Freue, Jose, Graciela Pilnik, Norma, Salvador Palazzo, Felipe, McGrath, Margaret, Fureder, Thorsten, Kornek, Gabriela, Pichler, Angelika, Bauernhofer, Thomas, Tinchon, Christoph, Greil, Richard, Burian, Martin, Kienzer, Heinz, Specenier, Pol, Sautois, Brieuc, Debruyne, Philip, Graas, Marie-Pascale, Maes, Annelies, Lonchay, Christophe, Daisne, Jean-Francois, Fontaine, Christel, Castro Junior, Gilberto, de Oliveira, Frias, Pereira, Rodrigo Perez, Martins De Marchi, Pedro Rafael, Lazaretti, Nicolas Silva, Kulkarni, Swati, Alam, Yasmin, Ho, Cheryl, Shenouda, George, Soulieres, Denis, Sultanem, Khalil, Singh, Simron, Gonzalez Mella, Pablo, Solis Campos, Jose Antonio, Prausova, Jana, Obermannova, Radka, Friborg, Jeppe, Specht, Lena, Elsaid, Amr Abdelaziz, Minn, Heikki, Martin, Laurent, Rolland, Frederic, Ceruse, Philippe, Calais, Gilles, Guigay, Joe, Ferte, Charles, Peyrade, Frederic, Duffaud, Florence, Champeaux-Orange, Elise, Coutte, Alexandre, Clatot, Florian, Fournel, Pierre, Le Moal, Laurence Bozec, Dietz, Andreas, Gruenwald, Viktor, Gauler, Thomas, Guntinas-Lichius, Orlando, Hildebrandt, Guido, Kuhnt, Thomas, Schmidt, Horst-Juergen, Henke, Michael, Rueckert, Anja, Brugger, Wolfram, Rotter, Nicole, Mahlberg, Rolf, Karavasilis, Vasilios, Fountzilas, Georgios, Psyrri, Diamanto, Lang, Istvan, Boer, Andras, Kocsis, Judit, Pajkos, Gabor, Tamas, Laszlo, Anand, A. L., Sharma, Ajay, Sharma, Voona, Murali, Pandy, Ananda Selvakumar, Kumar, Kirushna, Nathan, Raj Kumar Poovna, Srinivasan, Venkatesan, Zade, Bhooshan, Jain, Minish, Srinivasa, B. J., Naik, Radheshyam, Mohanty, B. K., Charas, Tomer, Billan, Salem, Popovtzer, Aron, Licitra, Lisa, Ferrari, Daris, Fao, Paolo, Merlano, Marco, Rocca, Maria Cossu, Fujii, Hirofumi, Minami, Syujiro, Fujii, Masato, Kadowaki, Shigenori, Muro, Kei, Okami, Kenji, Yagi, Toshinari, Yoshino, Kunitoshi, Matsumoto, Koji, Takahashi, Shunji, Matsuura, Kazuto, Alvarez Avitia, Miguel Angel, Gonzalez Riestra, Hector Jorge, van Meerten, E., Buter, J., Gelderblom, A. J., Kawecki, Andrzej, Golusinski, Wojciech, Dinis, Rui, Ribeiro, Leonor, Silva, Regina, Mansinho, Helder, Selezneva, Irina, Biakhov, Mikhail, Galiulin, Rinat, Izmailov, Adel, Vladimirov, Vladimir, Vinogradov, Valery, Mufazalov, Fagim, Baste, Neus, Ma del Campo, Josep, Mesia Nin, Ricard, Lopez Pousa, Antonio, Jose Grau de Castro, Juan, Reig, Oscar, Vera, Ruth, Trigo, JoseManuel, Iglesias, Lara, Martinez Trufero, Javier, Vazquez, Sergio, Rubio, Belen, Enrique Ales, Jose, Villar, Esther, Rubio, Jordi, Escobar, Yolanda, Soria, Ainara, Chaves, Mauel, Johansson, Gun Wickart, Friesland, Signe, Tell, Roger, Nyman, Jan, Rothschild, Sacha, Zippelius, Alfred, Usluoglu, Nurguel, Gogunska, Inna, Zabolotniy, Dmytro, Vinnyk, Yuriy, Burian, Oleksandr, Sykes, Andrew, Peel, David, Lester, James, Robinson, Martin, Srinivasan, Devraj, Fragkandrea-Nixon, Ioanna, Junor, Elizabeth, Gollins, Simon, Evans, Mererid, Newbold, Kate, Hwang, David, Schipani, Stefano, Rizwanullah, Mohammed, Atiq, Omar, Arnaoutakis, Konstantinos, Bauman, Jessica, Mehra, Ranee, Kang, Hyunseok, Chung, Christine, Davis, Thomas, Jimeno, Antonio, Keresztes, Roger, Nangia, Chaitali, Ignatius, Sai-Hong, Su, Yungpo Bernard, Overton, Lindsay Carol, Garrison, Mitchell A., Jeong, Woondong, Wehbe, Ahmad, Argiris, Athanassios, Chiang, Anne, Morgensztern, Daniel, Haigentz, Missak, Jr., Martincic, Danko, Porosnicu, Mercedes, LUX-HEAD & Neck 2 Investigators, Medical Oncology, and Boehringer Ingelheim Fonds

Subjects
Oncology, Cancer Research, medicine.medical_specialty, animal structures, Afatinib, Population, Medizin, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, mental disorders, medicine, Adjuvant therapy, Clinical endpoint, 030212 general & internal medicine, education, 610 Medicine & health, Original Investigation, education.field_of_study, business.industry, food and beverages, medicine.disease, Head and neck squamous-cell carcinoma, 030220 oncology & carcinogenesis, bacteria, sense organs, Human medicine, business, Chemoradiotherapy, medicine.drug
Abstract

LUX-Head & Neck 2 investigators., [Importance] Locoregionally advanced head and neck squamous cell cancer (HNSCC) is treated curatively; however, risk of recurrence remains high among some patients. The ERBB family blocker afatinib has shown efficacy in recurrent or metastatic HNSCC., [Objective] To assess whether afatinib therapy after definitive chemoradiotherapy (CRT) improves disease-free survival (DFS) in patients with HNSCC., [Design, Setting, and Participants] This multicenter, phase 3, double-blind randomized clinical trial (LUX-Head & Neck 2) studied 617 patients from November 2, 2011, to July 4, 2016. Patients who had complete response after CRT, comprising radiotherapy with cisplatin or carboplatin, with or without resection of residual disease, for locoregionally advanced high- or intermediate-risk HNSCC of the oral cavity, hypopharynx, larynx, or oropharynx were included in the study. Data analysis was of the intention-to-treat population., [Interventions] Patients were randomized (2:1) to treatment with afatinib (40 mg/d) or placebo, stratified by nodal status (N0-2a or N2b-3) and Eastern Cooperative Oncology Group performance status (0 or 1). Treatment continued for 18 months or until disease recurrence, unacceptable adverse events, or patient withdrawal., [Main Outcomes and Measures] The primary end point was DFS, defined as time from the date of randomization to the date of tumor recurrence or secondary primary tumor or death from any cause. Secondary end points were DFS at 2 years, overall survival (defined as time from the date of randomization to death), and health-related quality of life., [Results] A total of 617 patients were studied (mean [SD] age, 58 [8.4] years; 528 male [85.6%]). Recruitment was stopped after a preplanned interim futility analysis on July 4, 2016, on recommendation from an independent data monitoring committee. Treatment was discontinued. Median DFS was 43.4 months (95% CI, 37.4 months to not estimable) in the afatinib group and not estimable (95% CI, 40.1 months to not estimable) in the placebo group (hazard ratio, 1.13; 95% CI, 0.81-1.57; stratified log-rank test P = .48). The most common grade 3 and 4 drug-related adverse effects were acneiform rash (61 [14.8%] of 411 patients in the afatinib group vs 1 [0.5%] of 206 patients in the placebo group), stomatitis (55 [13.4%] in the afatinib group vs 1 [0.5%] in the placebo group), and diarrhea (32 [7.8%] in the afatinib group vs 1 [0.5%] in the placebo group)., [Conclusions and Relevance] This study’s findings indicate that treatment with afatinib after CRT did not improve DFS and was associated with more adverse events than placebo in patients with primary, unresected, clinically high- to intermediate-risk HNSCC. The use of adjuvant afatinib after CRT is not recommended., [Trial Registration] ClinicalTrials.gov identifier: NCT01345669., The study was funded by Boehringer Ingelheim.

Published
2019

25. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study

Author

Harrington, Kevin, primary, Temam, Stephane, additional, Mehanna, Hisham, additional, D'Cruz, Anil, additional, Jain, Minish, additional, D'Onofrio, Ida, additional, Manikhas, Georgy, additional, Horvath, Zsuzsanna, additional, Sun, Yan, additional, Dietzsch, Stefan, additional, Dubinsky, Pavol, additional, Holeckova, Petra, additional, El-Hariry, Iman, additional, Franklin, Natalie, additional, Biswas-Baldwin, Nigel, additional, Legenne, Philippe, additional, Wissel, Paul, additional, Netherway, Thelma, additional, Farrell, John, additional, Ellis, Catherine, additional, Wang-Silvanto, Jing, additional, Amonkar, Mayur, additional, Ahmed, Nazma, additional, Santillana, Sergio, additional, and Bourhis, Jean, additional

Published
2015
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26. Complete remission of rare adenocarcinoma of the oropharynx with APCEDEN® (dendritic cell-based vaccine): a case report.

Author

Kumar, Chaitanya, Kohli, Sakshi, Chiliveru, Srikanth, Jain, Minish, and Sharan, Bandana

Subjects
IMMUNOTHERAPY, DENDRITIC cells, CANCER treatment, ADENOCARCINOMA, GEFITINIB, OROPHARYNGEAL cancer, HEAD & neck cancer, THERAPEUTICS
Abstract

Key Clinical Message APCEDEN® is an autologous monocyte-derived dendritic cell-based immunotherapy. A 58-year-old man with adenocarcinoma of oropharynx shows complete remission after receiving APCEDEN® in conjunction with Geftinib validated by reduction in size, whereas Gefitinib alone lead to disease progression. [ABSTRACT FROM AUTHOR]

Published
2017
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29. Key Results of International Randomized Open-Label Clinical Study of BCD-020 (rituximab biosimilar candidate) in Patients with B-Cell Non-Hodgkin’s Lymphoma

Author

Kaplanov, Kamil, primary, Zaritskiy, Andrey, additional, Alexeev, Sergey, additional, Volodicheva, Elena, additional, Loginov, Alexander, additional, Orlova, Rashida, additional, Dvornichenko, Victoria, additional, Kosinova, Marina, additional, Serduk, Olga, additional, Milovanov, Vladimir, additional, Myasnikov, Alexander, additional, Patil, Shekar, additional, Rangarajan, Bharath, additional, Rajappa, Senthil Jagannathan, additional, Jain, Minish, additional, Nirni, Sharanabasappa, additional, Deka, Akhil, additional, Rekhtman, Grigoriy B, additional, Kryachok, Iryna, additional, Maslyak, Zvenyslava, additional, Chernyaeva, Ekaterina, additional, Ivanov, Roman, additional, and Isaev, Alexander, additional

Published
2014
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33. Comparison of pharmacokinetics and pharmacodynamics of BCD-020 with innovator rituximab in patients with indolent non-Hodgkin lymphoma.

Author

Poddubnaya, I., primary, Babicheva, L., additional, Kaplanov, K., additional, Zaritskey, Andrey, additional, Volodicheva, E., additional, Alexeev, S., additional, Loginov, A., additional, Orlova, R., additional, Dvornichenko, V., additional, Gladkov, Oleg, additional, Kosinova, M., additional, Serduk, O., additional, Milovanov, V., additional, Myasnikov, A., additional, Suresh, Attili Venkatasatya, additional, Jain, Minish, additional, Patil, S., additional, Rajappa, Senthil Jagannathan, additional, Ivanov, R., additional, and Chernyaeva, E., additional

Published
2014
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34. The efficacy and safety of paclitaxel injection concentrate for nano-dispersion (PICN) at two different doses versus paclitaxel albumin-stabilized nanoparticle formulation in subjects with metastatic breast cancer (MBC).

Author

Jain, Minish Mahendra, primary, Patil, Shekhar, additional, Pathak, Anand Bhaskarrao, additional, Deshmukh, Chetan Dilip, additional, Bhatt, Niraj, additional, Babu, K Govind, additional, Haritha, Chiramana, additional, Bondarde, Shailesh Arjun, additional, Digumarti, Raghunadharao, additional, Bajpai, Jyoti, additional, Kumar, Ravi, additional, Gupte, Smita Uday, additional, Bakshi, Ashish Vijay, additional, Bhattacharyya, Gouri Shankar, additional, Patil, Poonam, additional, Subramanian, S, additional, Vaid, Ashok K., additional, Desai, Chirag Jyotiker, additional, Bapsy, P P, additional, and Divekar, Ganesh, additional

Published
2014
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35. An international, multicenter, randomized, double-blind phase III study of maintenance belagenpumatucel-l in non-small cell lung cancer (NSCLC): Updated analysis of patients enrolled within 12 weeks of completion of chemotherapy.

Author

Bazhenova, Lyudmila, primary, Giaccone, Giuseppe, additional, Nemunaitis, John J., additional, Juhász, Erzsébet, additional, Ramlau, Rodryg, additional, van den Heuvel, Michel M, additional, Lal, Rohit, additional, Dunlop, David, additional, Garon, Edward B., additional, Chu, Quincy S., additional, Jain, Minish Mahendra, additional, Carrier, Ewa, additional, Moses, Steven, additional, Shawler, Daniel, additional, and Fakhrai, Habib, additional

Published
2014
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37. Randomized, blinded, placebo-controlled phase II trial of docetaxel and bavituximab as second-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer.

Author

Shtivelband, Mikhail, primary, Spigel, David R., additional, Gerber, David E., additional, Jain, Minish Mahendra, additional, Ponomarova, Olga V., additional, Giorgadze, Davit, additional, Shan, Joseph, additional, Menander, Kerstin B., additional, and Belani, Chandra Prakash, additional

Published
2013
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38. Phase Ib extension study of eribulin mesylate in combination with carboplatin in patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC).

Author

Raftopoulos, Harry, primary, Aisner, Joseph, additional, Kumar, Kirushna, additional, Goel, Sanjay, additional, Dittrich, Christian, additional, Jain, Minish, additional, Gopalakrishna, Prashanth, additional, Salazar, Paloma, additional, Jones, Beverley, additional, and Petrylak, Daniel Peter, additional

Published
2013
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42. Lack of efficacy of adjuvant lapatinib in HER2-negative breast cancer (HER2–ve BC): Analysis of patients in the TEACH trial.

Author

Chavarri Guerra, Yanin, primary, Chan, Arlene, additional, Finkelstein, Dianne M., additional, Chan, Valorie F., additional, Harvey, Vernon J., additional, Lee, Keun Seok, additional, Jain, Minish Mahendra, additional, Petrakova, Katarina, additional, Raina, Vinod, additional, Xu, Binghe, additional, Gomez, Henry, additional, Rappold, Erica, additional, Kaneko, Tomomi, additional, Huang, Yingjie, additional, and Goss, Paul E., additional

Published
2013
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43. A double-blind, randomised, placebo-controlled, phase 2b study evaluating sorafenib in combination with paclitaxel as a first-line therapy in patients with HER2-negative advanced breast cancer

Author

Gradishar, William J., primary, Kaklamani, Virginia, additional, Sahoo, Tarini P., additional, Lokanatha, Dasappa, additional, Raina, Vinod, additional, Bondarde, Shailesh, additional, Jain, Minish, additional, Ro, Sunhee Kwon, additional, Lokker, Nathalie A., additional, and Schwartzberg, Lee, additional

Published
2013
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45. A phase I study of selective cyclin dependent kinase inhibitor P1446A-05 administered on an intermittent schedule in patients with advanced refractory tumors.

Author

Gupta, Sudeep, primary, Jain, Minish Mahendra, additional, Maru, Anish, additional, Nag, Shona Milon, additional, Somani, Naresh, additional, Mehta, Ajay O., additional, Kulkarni, Sujay, additional, Acharya, Shivani Anil, additional, Dhobe, Poornima, additional, and Jadhav, Nitin, additional

Published
2012
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47. Abstract 4606: Randomized phase 2 study of efatutazone in combination with carboplatin and paclitaxel as first-line therapy for metastatic non-small cell lung cancer (NSCLC)

Author

Shaw, Alice T., primary, Ghizdavescu, Doru, additional, Jain, Minish, additional, Volovat, Constantin, additional, Subramaniam, Deepa, additional, Shuster, Dale, additional, Jin, Xiaoping, additional, Dutta, Dipen, additional, Pai, Seema, additional, and von Roemeling, Reinhard, additional

Published
2012
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48. A Phase 1 Trial of Fluphenazine HCl (Fz), a Serotonin Antagonist, in Relapsed and Refractory Multiple Myeloma

Author

Stadtmauer, Edward A., primary, Siegel, David, primary, Vogl, Dan T, primary, Stinnett, James, primary, Narayanan, Geetha, primary, Bapsy, P.P., primary, Ganesan, Trivadi, primary, Jain, Minish, primary, Prasad, Sripada V.S.S, primary, McNair, Douglas S, primary, DeYoung, Linda, primary, Lane, Alice, primary, and Silver, Bruce, primary

Published
2008
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49. Substantial remission of prostate adenocarcinoma with dendritic cell therapy APCEDEN ® in combination with chemotherapy.

Author

Kumar C, Bagga J, Chiliveru S, Kohli S, Bharadwaj A, Jain M, Inamdar S, and Sharan B

Abstract

Of the most prevalent solid tumors with advanced disease, prostate and ovarian cancer and non-small cell lung carcinoma have the fewest therapeutic options. Herein, we report the case of a 63-year-old male with metastatic prostate adenocarcinoma showing substantial remission post-administration of personalized dendritic cell-based vaccine APCEDEN ® in combination with chemotherapeutic drug Mitoxantrone. Therapeutic response displayed an interesting clinical correlation validated by PET scan images showing decreased fluorodeoxyglucose (FDG) avidity in the prostate gland, reduced skeletal metastases further established by the drop in serum Prostate Specific Antigen (PSA) levels and expression of immune assessment markers (IFN-γ, Tregs, neutrophil lymphocyte ratio and platelet lymphocyte ratio). This case demonstrates the potential efficacy of dendritic cell immunotherapy, showing a potent antitumor activity by enhancing the host immune responses, and improving quality of life., Competing Interests: Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript., (© 2019 APAC Biotech PVT Ltd.)

Published
2019
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50. Complete remission of rare adenocarcinoma of the oropharynx with APCEDEN ® (dendritic cell-based vaccine): a case report.

Author

Kumar C, Kohli S, Chiliveru S, Jain M, and Sharan B

Abstract

APCEDEN ® is an autologous monocyte-derived dendritic cell-based immunotherapy. A 58-year-old man with adenocarcinoma of oropharynx shows complete remission after receiving APCEDEN ® in conjunction with Geftinib validated by reduction in size, whereas Gefitinib alone lead to disease progression.

Published
2017
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