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12 results on '"Zancong Shen"'

1. Supplementary Table 2 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Grade 3 or 4 adverse events possibly related to refametinib or sorafenib, occurring in {greater than or equal to}2 patients in either cohort

Published
2023

2. Data from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Prabhu Rajagopalan, Michael Jeffers, Ronald L. Dubowy, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Beth Sheedy, Wen W. Ma, Grace K. Dy, Ramesh K. Ramanathan, Glen J. Weiss, Karl D. Lewis, Lia Gore, S. Gail Eckhardt, Diane P. Leffingwell, Alex A. Adjei, Daniel D. Von Hoff, and Colin D. Weekes

Abstract

Purpose: To evaluate the safety, pharmacokinetics, and pharmacodynamics of BAY 86-9766, a selective, potent, orally available, small-molecule allosteric inhibitor of mitogen-activated protein kinase 1/2 in patients with advanced solid tumors.Experimental Design: BAY 86-9766 was administered orally daily in 28-day courses, with doses escalated to establish the maximum-tolerated dose (MTD). An expanded cohort was evaluated at the MTD. Pharmacokinetic and pharmacodynamic parameters were assessed, with extracellular signal–regulated kinase (ERK) phosphorylation evaluated in paired biopsies from a subset of the expanded MTD cohort. Tumor specimens were evaluated for mutations in select genes.Results: Sixty-nine patients were enrolled, including 20 patients at the MTD. The MTD was 100 mg given once-daily or in two divided doses. BAY 86-9766 was well-tolerated. The most common treatment-related toxicities were acneiform rash and gastrointestinal toxicity. BAY 86-9766 was well-absorbed after oral administration (plasma half-life ∼12 hours), and displayed dose proportional pharmacokinetics throughout the tested dose range. Continuous daily dosing resulted in moderate accumulation at most dose levels. BAY 86-9766 suppressed ERK phosphorylation in biopsied tissue and tetradecanoylphorbol acetate–stimulated peripheral blood leukocytes. Of 53 evaluable patients, one patient with colorectal cancer achieved a partial response and 11 patients had stable disease for 4 or more courses. An ocular melanoma specimen harbored a GNAQ-activating mutation and exhibited reduced ERK phosphorylation in response to therapy.Conclusion: This phase I study showed that BAY 86-9766 was well-tolerated, with good oral absorption, dose proportional pharmacokinetics, target inhibition at the MTD, and some evidence of clinical benefit across a range of tumor types. Clin Cancer Res; 19(5); 1232–43. ©2012 AACR.

Published
2023

3. Supplementary Table 3 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Overview of dose-limiting toxicities and adverse events leading to discontinuation and relationship to study treatment

Published
2023

4. Supplementary Table 5 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Refametinib geometric mean (% coefficient of variation) multiple-dose pharmacokinetic data on day 1 of course 2

Published
2023

5. Supplementary Table 1 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Incidence of treatment-emergent adverse events, all grades, occurring in {greater than or equal to}20% of patients in either cohort

Published
2023

6. Supplementary Figure 2 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

CTC enumeration and pERK analysis in course 1

Published
2023

7. Supplementary Tables 1-3 from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Prabhu Rajagopalan, Michael Jeffers, Ronald L. Dubowy, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Beth Sheedy, Wen W. Ma, Grace K. Dy, Ramesh K. Ramanathan, Glen J. Weiss, Karl D. Lewis, Lia Gore, S. Gail Eckhardt, Diane P. Leffingwell, Alex A. Adjei, Daniel D. Von Hoff, and Colin D. Weekes

Abstract

Table S1: Dose-limiting toxicities; Table S2:Multiple-dose pharmacokinetic parameters (geometric mean (%CV) of BAY 86-9766 and metabolite M17 on Course 1, Day 22 (representing exposure after 15 days of continuous dosing) for once-daily dosing cohorts; Table S3: Multiple-dose pharmacokinetic parameters of BAY 86-9766 and metabolite M17 on Course 1, Day 22 (representing exposure after 15 days of continuous dosing) for twice-daily dosing cohorts

Published
2023

8. Supplementary Figure 1 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

pERK levels in hair follicles by dose level and course

Published
2023

9. Supplementary Figure Legend from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Prabhu Rajagopalan, Michael Jeffers, Ronald L. Dubowy, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Beth Sheedy, Wen W. Ma, Grace K. Dy, Ramesh K. Ramanathan, Glen J. Weiss, Karl D. Lewis, Lia Gore, S. Gail Eckhardt, Diane P. Leffingwell, Alex A. Adjei, Daniel D. Von Hoff, and Colin D. Weekes

Abstract

Legend for supplementary figure

Published
2023

10. Supplementary Table 4 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Refametinib geometric mean (% coefficient of variation) single-dose pharmacokinetic data on day 1 of course 1

Published
2023

11. Supplementary Figure S1 from Multicenter Phase I Trial of the Mitogen-Activated Protein Kinase 1/2 Inhibitor BAY 86-9766 in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Prabhu Rajagopalan, Michael Jeffers, Ronald L. Dubowy, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Beth Sheedy, Wen W. Ma, Grace K. Dy, Ramesh K. Ramanathan, Glen J. Weiss, Karl D. Lewis, Lia Gore, S. Gail Eckhardt, Diane P. Leffingwell, Alex A. Adjei, Daniel D. Von Hoff, and Colin D. Weekes

Abstract

Treatment schema

Published
2023

12. Supplementary Table 6 from A Phase I Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Combination Therapy with Refametinib plus Sorafenib in Patients with Advanced Cancer

Author

Neil J. Clendeninn, Heiko Krissel, Prabhu Rajagopalan, Kimberly J. Manhard, David M. Wilson, Sonny Gunawan, Li-Tain Yeh, Zancong Shen, Jeffrey N. Miner, Cory Iverson, Diane P. Leffingwell, Lawrence Garbo, Morris Sherman, Aram F. Hezel, Joe J. Stephenson, Carlos H.R. Becerra, Fadi Braiteh, Anthony El-Khoueiry, Donald A. Richards, and Alex A. Adjei

Abstract

Sorafenib geometric mean (% coefficient of variation) multiple-dose pharmacokinetic data on day 1 of course 2

Published
2023

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