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152. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial

Author

Murray, Miranda I., Markowitz, Martin, Frank, Ian, Grant, Robert M., Mayer, Kenneth H., Hudson, Krischan J., Stancil, Britt S., Ford, Susan L., Patel, Parul, Rinehart, Alex R., Spreen, William R., and Margolis, David A.

Abstract

Background: Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a long-acting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP). Objective: We report participant outcomes from the phase IIa ECLAIR study related to tolerability, acceptability, and satisfaction of cabotegravir LA. Methods: The ECLAIR study (ClinicalTrials.gov identifier, NCT02076178) was a randomized, placebo-controlled study in healthy men not at high risk of acquiring HIV-1. Participants were randomized (5:1) to once-daily oral cabotegravir 30 mg or placebo tablets for 4 weeks, followed by gluteal intramuscular injections of cabotegravir LA 800 mg or saline placebo every 12 weeks. The primary objective was to evaluate the safety of cabotegravir LA over three injection cycles (to Week 41). Secondary objectives assessed the tolerability, satisfaction, and acceptability of cabotegravir LA. Results: Among 115 participants who received injections in the cabotegravir (n = 94) and placebo (n = 21) groups, 93% (n = 87) and 95% (n = 20) completed the injection phase, respectively. Injection intolerability led to withdrawal in 4 participants (4%) receiving cabotegravir LA. The most frequently reported Grade ≥2 adverse event was injection-site pain. Most participants (74% [n = 67]) receiving consecutive injections favored cabotegravir LA vs oral cabotegravir. Most participants were satisfied with cabotegravir LA (75% [n = 64]), were willing to continue (79% [n = 68]), and would recommend (87% [n = 75]) the therapy. Conclusions: While Grade ≥2 injection-site pain was common, most participants reported overall satisfaction with and preference for cabotegravir LA, with few discontinuations due to injection intolerance. These findings support investigation of cabotegravir LA as an alternative to daily oral PrEP regimens.

Published
2018
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153. Genomic profiling of NETs : A comprehensive analysis of the RADIANT trials

Author

Yao, James, Garg, Amit, Chen, David, Capdevila Castillón, Jaume, Engstrom, Paul, Pommier, Rodney, Van Cutsem, Eric, Singh, Simron, Fazio, Nicola, He, Wei, Riester, Markus, Patel, Parul, Voi, Maurizio, Morrissey, Michael, Pavel, Marianne, Helmut Kulke, Matthew., and Universitat Autònoma de Barcelona

Subjects
Male, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Multivariate analysis, Endocrinology, Diabetes and Metabolism, Antineoplastic Agents, Neuroendocrine tumors, Neuroemdocrine tumors, Endocrinology & Metabolism, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Internal medicine, Chromosome instability, Exome Sequencing, medicine, Humans, Clinical significance, Everolimus, Exome sequencing, Aged, Science & Technology, LANDSCAPE, biology, business.industry, High-Throughput Nucleotide Sequencing, Chromogranin A, Genomics, medicine.disease, Chromosomal instability, Clinical trial, Neuroendocrine Tumors, Clinical biomarkers, ATRX, 030104 developmental biology, 030220 oncology & carcinogenesis, Mutation, SURVIVAL, DAXX, biology.protein, Biomarker (medicine), Female, neuroendocrine tumors, business, Life Sciences & Biomedicine
Abstract

Neuroendocrine tumors (NETs) have historically been subcategorized according to histologic features and the site of anatomic origin. Here, we characterize the genomic alterations in patients enrolled in 3 phase 3 clinical trials of NET of different anatomic origins and assessed the potential correlation with clinical outcomes. Whole-exome and targeted panel sequencing was used to characterize 225 NET samples collected in the RADIANT series of clinical trials. Genomic profiling of NET was analyzed along with nongenomic biomarker data on tumor grade and circulating chromogranin A (CgA) and neuron specific enolase (NSE) levels from these patients enrolled in clinical trials. Our results highlight recurrent large-scale chromosomal alterations as a common theme among NET. Although the specific pattern of chromosomal alterations differed between tumor subtypes, the evidence for generalized chromosomal instability (CIN) was observed across all primary sites of NET. In pancreatic NET, although the P-value was not significant, higher CIN suggests a trend towards longer survival (HR, 0.55, P=0.077); whereas in the gastrointestinal NET, lower CIN was associated with longer survival (HR, 0.44, P=0.0006). Our multivariate analyses demonstrated that when combined with other clinical data among patients with progressive advanced NETs, chromosomal level alteration adds important prognostic information. Large-scale CIN is a common feature of NET, and specific patterns of chromosomal gain and loss appeared to have independent prognostic value in NET subtypes. However, whether CIN in general has clinical significance in NET requires validation in larger patient cohort and warrants further mechanistic studies. ispartof: ENDOCRINE-RELATED CANCER vol:26 issue:4 pages:391-403 ispartof: location:England status: published

Published
2018

158. Genomic profiling of NETs: a comprehensive analysis of the RADIANT trials

Author

Yao, James, primary, Garg, Abhishek, additional, Chen, David, additional, Capdevila, Jaume, additional, Engstrom, Paul, additional, Pommier, Rodney, additional, Van Cutsem, Eric, additional, Singh, Simron, additional, Fazio, Nicola, additional, He, Wei, additional, Riester, Markus, additional, Patel, Parul, additional, Voi, Maurizio, additional, Morrissey, Michael, additional, Pavel, Marianne, additional, and Kulke, Matthew Helmut, additional

Published
2019
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159. Transcriptomic Profiling of the Tumor Microenvironment Reveals Distinct Subgroups of Clear Cell Renal Cell Cancer: Data from a Randomized Phase III Trial

Author

Hakimi, A. Ari, primary, Voss, Martin H., additional, Kuo, Fengshen, additional, Sanchez, Alejandro, additional, Liu, Ming, additional, Nixon, Briana G., additional, Vuong, Lynda, additional, Ostrovnaya, Irina, additional, Chen, Ying-Bei, additional, Reuter, Victor, additional, Riaz, Nadeem, additional, Cheng, Yuan, additional, Patel, Parul, additional, Marker, Mahtab, additional, Reising, Albert, additional, Li, Ming O., additional, Chan, Timothy A., additional, and Motzer, Robert J., additional

Published
2019
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163. PTEN Expression, Not Mutation Status in TSC1, TSC2, or mTOR, Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial

Author

Voss, Martin H., primary, Chen, David, additional, Reising, Albert, additional, Marker, Mahtab, additional, Shi, Jiayuan, additional, Xu, Jianning, additional, Ostrovnaya, Irina, additional, Seshan, Venkatraman E., additional, Redzematovic, Almedina, additional, Chen, Ying-Bei, additional, Patel, Parul, additional, Han, Xia, additional, Hsieh, James J., additional, Hakimi, A. Ari, additional, and Motzer, Robert J., additional

Published
2019
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164. Transcriptomic Signatures Related to the Obesity Paradox in Patients with Clear Cell Renal Cell Carcinoma

Author

Sanchez, Alejandro, primary, Furberg, Helena, additional, Kuo, Fengshen, additional, Vuong, Lynda, additional, Ged, Yasser, additional, Patil, Sujata, additional, Ostrovnaya, Irina, additional, Reising, Albert, additional, Patel, Parul, additional, Mano, Roy, additional, Coleman, Jonathan, additional, Russo, Paul, additional, Liu, Catherine H., additional, Dannenberg, Andrew J., additional, Chan, Timothy A., additional, Motzer, Robert, additional, Voss, Martin H., additional, and Hakimi, Abraham, additional

Published
2019
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166. Circulating Biomarkers and Resistance to Endocrine Therapy in Metastatic Breast Cancers: Correlative Results from AZD9496 Oral SERD Phase I Trial

Author

Paoletti, Costanza, primary, Schiavon, Gaia, additional, Dolce, Emily M., additional, Darga, Elizabeth P., additional, Carr, T. Hedley, additional, Geradts, Joseph, additional, Hoch, Matthias, additional, Klinowska, Teresa, additional, Lindemann, Justin, additional, Marshall, Gayle, additional, Morgan, Shethah, additional, Patel, Parul, additional, Rowlands, Vicky, additional, Sathiyayogan, Nitharsan, additional, Aung, Kimberly, additional, Hamilton, Erika, additional, Patel, Manish, additional, Armstrong, Anne, additional, Jhaveri, Komal, additional, Im, Seock-Ah, additional, Iqbal, Nadia, additional, Butt, Fouziah, additional, Dive, Caroline, additional, Harrington, Elizabeth A., additional, Barrett, J. Carl, additional, Baird, Richard, additional, and Hayes, Daniel F., additional

Published
2018
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170. A randomized, controlled trial of initial anti-retroviral therapy with abacavir/lamivudine/zidovudine twice-daily compared to atazanavir once-daily with lamivudine/zidovudine twice-daily in HIV-infected patients over 48 weeks (ESS100327, the ACTION Study)

Author

McClernon Daniel, Patel Parul, DeJesus Edwin, LaMarca Anthony, Salvato Patricia, Kumar Princy N, Florance Allison, and Shaefer Mark S

Subjects
Immunologic diseases. Allergy, RC581-607
Abstract

Abstract Background Traditional first line regimens containing a non-nucleoside reverse transcriptase inhibitor or protease inhibitor may not be suitable for a subset of antiretroviral-naïve patients such as those with certain co-morbidities, women of child-bearing potential, and intolerability to components of standard first line therapy. This study was conducted to determine if alternate treatment options may meet the needs of both general and special patient populations. The ACTION study was a randomized, open-label, multicenter, 48-week trial that compared the safety and efficacy of a triple nucleoside regimen versus a protease inhibitor plus a dual nucleoside regimen in HIV-1 treatment-naïve subjects. Results 279 HIV-infected subjects with HIV-1 RNA (VL) >5000 but < 200,000 copies/mL (c/mL) and CD4+ count ≥ 100 cells/mm3 were randomized (1:1) to receive abacavir sulfate/lamivudine/zidovudine (ABC/3TC/ZDV) twice-daily or atazanavir (ATV) once-daily plus lamivudine/zidovudine (3TC/ZDV) twice-daily. Protocol-defined virologic failure was based on multiple failure criteria. Non-inferiority of ABC/3TC/ZDV to ATV+3TC/ZDV was established with 62% vs. 59% of subjects achieving a VL < 50 c/mL at week 48, [ITT(E), M/S = F, 95% CI: -5.9, 10.4]. Similar results were observed in the 230 (82%) subjects with baseline VL Conclusion ABC/3TC/ZDV demonstrated comparable virologic efficacy to ATV+3TC/ZDV in this population over 48 weeks. In those with a baseline VL ≥ 100,000 c/mL, subjects in the ATV+3TC/ZDV showed better virologic efficacy. Both regimens offer benefits in select therapy-naïve subjects. Trial Registration [Clinical Trials Identifier, NCT00082394].

Published
2009
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171. Use of multiincidence angle RADARSAT-1 SAR data to incorporate the effect of surface roughness in soil moisture estimation

Author

Srivastava, Hari Shanker, Patel, Parul, Manchanda, M.L., and Adiga, S.

Subjects
Synthetic aperture radar -- Research, Business, Earth sciences, Electronics and electrical industries
Abstract

The proposed study offers an approach to incorporate the effect of surface roughness in the estimation of soil moisture from space without actually measuring surface roughness conditions on ground. It is required to acquire synthetic aperture radar data at low and high incidence angles, such that the soil moisture changes are negligible between the two acquisitions. Index Terms--Backscatter coefficient ([[sigma].sup.o]), multiincidence angle synthetic aperture radar (SAR), surface roughness.

Published
2003

172. Population pharmacokinetics of the MEK inhibitor selumetinib and its active N-desmethyl metabolite:Data from 10 phase I trials

Author

Patel, Parul, Howgate, Eleanor, Martin, Paul, Carlile, David J., Aarons, Leon, and Zhou, Diansong

Subjects
Adult, Male, Antifungal Agents, Selumetinib, Administration, Oral, Biological Availability, Models, Biological, Young Adult, Phase I, Metabolites, Humans, Drug Interactions, Pharmacokinetics, Pharmacology (medical), Carbon Radioisotopes, Protein Kinase Inhibitors, Aged, Mitogen-Activated Protein Kinase Kinases, Pharmacology, Clinical Trials, Phase I as Topic, Cytochrome P-450 CYP3A Inducers, Middle Aged, Healthy Volunteers, Linear Models, Cytochrome P-450 CYP2C19 Inhibitors, Cytochrome P-450 CYP3A Inhibitors, Administration, Intravenous, Benzimidazoles, Drug Therapy, Combination, Female
Abstract

Aims: The aims of the study were to characterize the pharmacokinetics (PK) of selumetinib (AZD6244; ARRY-142886), a mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor in clinical development for various indications, and its N-desmethyl metabolite in healthy volunteers, and evaluate clinically important covariates. Methods: A pooled-population PK analysis was performed using a nonlinear mixed-effects approach with plasma concentration data from 346 subjects who received single oral doses of selumetinib 20-75 mg across 10 phase I studies. Absolute bioavailability was determined using intravenous [14C] selumetinib. Results: A two-compartment linear model with sequential zero-first order absorption and a lag time for the zero-order process was described for selumetinib PK. N-desmethyl metabolite disposition was described by a single compartment with linear elimination, without back transformation. The parent-only and joint models generally described pooled data adequately. For the median subject, not taking interacting drugs, estimates for clearance (CL) and central volume of distribution (V2) for selumetinib in the final joint model were 12.7 l h-1 and 35.6 l, respectively. Food effects, comedication with itraconazole [a cytochrome P450 (CYP) 3A4 inhibitor], fluconazole (a CYP2C19 inhibitor) and rifampicin (a CYP3A4 inducer) and formulation effects were incorporated into the base model a priori. Race and hepatic function were also influential in the PK model. Additional covariates affecting selumetinib disposition identified from covariate analysis were age on V2, bilirubin on CL, and weight on CL and V2. Conclusions: Analysis confirmed previous clinical pharmacology study findings of drug-drug interactions and food effects, with additional covariates that influence selumetinib and N-desmethyl selumetinib PK identified. Dose modifications based on these additional covariates were not considered necessary.

Published
2017

173. Wheat leaf area index retrieval using RISAT-1 hybrid polarized SAR data.

Author

Sivasankar, Thota, Kumar, Dheeraj, Shanker Srivastava, Hari, and Patel, Parul

Subjects
LEAF area index, HAZE, WHEAT, REMOTE-sensing images, FLUX (Energy), WEATHER
Abstract

Leaf Area Index (LAI) is a key parameter to characterize the canopy–atmosphere interface, where most of the energy fluxes exchange. Space-borne satellite images have shown their relevance for various applications including LAI retrieval over large areas. Although optical data have been used for this purpose in previous studies, the constraints to acquire optical data during extreme weather conditions due to the presence of clouds, haze, smoke etc. hinders its use for uninterrupted monitoring. This study aims to analyze the relationships of C-band RISAT-1 hybrid polarized SAR data (σ˚RH and σ˚RV) with wheat LAI. The results have shown the correlation coefficient (|r|) of 0.57 and 0.73 for RH and RV backscatter, respectively, using non-linear regression approach. It is also observed that the accuracy of LAI retrieval has been significantly improved with |r| and RMSE of 0.81 and 0.54 (m2/m2), respectively, by considering both RH and RV backscatter as inputs for support vector machine-based model. [ABSTRACT FROM AUTHOR]

Published
2020
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175. Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial

Author

Murray, Miranda I., primary, Markowitz, Martin, additional, Frank, Ian, additional, Grant, Robert M., additional, Mayer, Kenneth H., additional, Hudson, Krischan J., additional, Stancil, Britt S., additional, Ford, Susan L., additional, Patel, Parul, additional, Rinehart, Alex R., additional, Spreen, William R., additional, and Margolis, David A., additional

Published
2018
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176. Characterizing tumor immune microenvironment (TME) and outcomes for 409 patients (pts) treated on COMPARZ: Distinct clusters emphasize immune infiltration vs. angiogenesis.

Author

Voss, Martin Henner, primary, Kuo, Fengshen, additional, Sanchez, Alejandro, additional, Ostrovnaya, Irina, additional, Cheng, Yuan, additional, Patel, Parul, additional, Marker, Mahtab, additional, Reising, Albert, additional, Chan, Timothy An-thy, additional, Motzer, Robert J., additional, and Hakimi, A. Ari, additional

Published
2018
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184. Integrated biomarker analysis for 412 renal cell cancer (RCC) patients (pts) treated on the phase 3 COMPARZ trial: Correlating common mutation events in PBRM1 and BAP1 with angiogenesis expression signatures and outcomes on tyrosine kinase inhibitor (TKI) therapy.

Author

Voss, Martin Henner, primary, Kuo, Fengshen, additional, Chen, David, additional, Marker, Mahtab, additional, Patel, Parul, additional, Redzematovic, Almedina, additional, Riaz, Nadeem, additional, Chan, Timothy A., additional, Choueiri, Toni K., additional, Hsieh, James, additional, Motzer, Robert J., additional, and Hakimi, A. Ari, additional

Published
2017
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186. Genomic Biomarkers of a Randomized Trial Comparing First-line Everolimus and Sunitinib in Patients with Metastatic Renal Cell Carcinoma

Author

Hsieh, James J., primary, Chen, David, additional, Wang, Patricia I., additional, Marker, Mahtab, additional, Redzematovic, Almedina, additional, Chen, Ying-Bei, additional, Selcuklu, S. Duygu, additional, Weinhold, Nils, additional, Bouvier, Nancy, additional, Huberman, Kety H., additional, Bhanot, Umesh, additional, Chevinsky, Michael S., additional, Patel, Parul, additional, Pinciroli, Patrizia, additional, Won, Helen H., additional, You, Daoqi, additional, Viale, Agnes, additional, Lee, William, additional, Hakimi, A. Ari, additional, Berger, Michael F., additional, Socci, Nicholas D., additional, Cheng, Emily H., additional, Knox, Jennifer, additional, Voss, Martin H., additional, Voi, Maurizio, additional, and Motzer, Robert J., additional

Published
2017
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189. Correlation between PIK3CA mutations in cell-free DNA and everolimus efficacy in HR+, HER2− advanced breast cancer: results from BOLERO-2

Author

Moynahan, Mary Ellen, primary, Chen, David, additional, He, Wei, additional, Sung, Patricia, additional, Samoila, Aliaksandra, additional, You, Daoqi, additional, Bhatt, Trusha, additional, Patel, Parul, additional, Ringeisen, Francois, additional, Hortobagyi, Gabriel N, additional, Baselga, Jose, additional, and Chandarlapaty, Sarat, additional

Published
2017
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194. Prevalence of ESR1 Mutations in Cell-Free DNA and Outcomes in Metastatic Breast Cancer

Author

Chandarlapaty, Sarat, primary, Chen, David, additional, He, Wei, additional, Sung, Patricia, additional, Samoila, Aliaksandra, additional, You, Daoqi, additional, Bhatt, Trusha, additional, Patel, Parul, additional, Voi, Maurizio, additional, Gnant, Michael, additional, Hortobagyi, Gabriel, additional, Baselga, José, additional, and Moynahan, Mary Ellen, additional

Published
2016
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196. Effect of a High‐Fat Meal on the Pharmacokinetics of the HIV Integrase Inhibitor Cabotegravir.

Author

Patel, Parul, Ford, Susan L., Lou, Yu, Bakshi, Kalpana, Tenorio, Allan R., Zhang, Zhiping, Pan, Rennan, and Spreen, William

Subjects
*HIV, *HIV integrase inhibitors, *HIV prevention, *PHARMACOKINETICS, *BODY mass index, *INTEGRASE inhibitors
Abstract

Cabotegravir is an integrase inhibitor in clinical development for the treatment and prevention of HIV infection using oral tablets for short‐term, lead‐in use before subsequent administration of a long‐acting injectable formulation. This phase 1, single‐center, randomized, 2 × 2 crossover study evaluated the effect of a high‐fat meal on the pharmacokinetics (PK) of oral cabotegravir. Healthy adults received oral cabotegravir 30 mg as a single dose on 2 separate occasions, either after fasting or following a high‐fat meal (∼53% fat, ∼870 kcal). Safety evaluations and serial PK samples were collected, and a mixed‐effects model was used to determine within‐participant treatment comparison of noncompartmental PK parameters. Twenty‐four patients were enrolled and had a mean body mass index of 25.6 kg/m2; 67% were male. Compared with the fasting state, coadministration of cabotegravir with a high‐fat meal increased plasma cabotegravir area under the concentration‐time curve and maximal drug concentration, each by 14%. The slight 14% to 17% increase in exposure associated with a high‐fat, high‐calorie meal was not considered clinically significant. No grade 3/4 adverse events (AEs), drug‐related AEs, or AEs leading to discontinuation were reported. [ABSTRACT FROM AUTHOR]

Published
2019
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198. Correlation of PIK3CA mutations in cell-free DNA (cfDNA) and efficacy of everolimus (EVE) in metastatic breast cancer: Results from BOLERO-2.

Author

Moynahan, Mary Ellen, primary, Sung, Patricia, additional, Chen, David, additional, He, Wei, additional, Samoila, Aliaksandra, additional, You, Daoqi, additional, Bhatt, Trusha, additional, Patel, Parul, additional, Ringeisen, Francois Philippe, additional, Hortobagyi, Gabriel N., additional, Baselga, Jose, additional, and Chandarlapaty, Sarat, additional

Published
2016
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199. Differential overall survival (OS) results in RECORD-3 study based on three distinct mRCC molecular subgroups classified by BAP1 and/or PBRM1 mutations.

Author

Hsieh, James, primary, Chen, David, additional, Wang, Patricia, additional, Chen, Yingbei, additional, Marker, Mahtab, additional, Patel, Parul, additional, Chevinsky, Michael, additional, Bhanot, Umesh, additional, Pinciroli, Patrizia, additional, Berger, Michael F., additional, Cheng, Emily, additional, Lee, William, additional, Knox, Jennifer J., additional, Voss, Martin Henner, additional, Voi, Maurizio, additional, and Motzer, Robert J., additional

Published
2016
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