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Drug development and clinical trials--the path to an approved cancer drug

Nature reviews. Clinical oncology, 2012-04, Vol.9 (4), p.215-222

2012

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Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors

Journal for immunotherapy of cancer, 2022-01, Vol.10 (1), p.e003091

2022

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Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Clinical cancer research, 2016-06, Vol.22 (11), p.2623-2629

2016

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Antitumor activity in RAS-driven tumors by blocking AKT and MEK

Clinical cancer research, 2015-02, Vol.21 (4), p.739-748

2015

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Epothilones: Mechanism of Action and Biologic Activity

Journal of clinical oncology, 2004-05, Vol.22 (10), p.2015-2025

2004

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Phase I Study of Eribulin Mesylate Administered Once Every 21 Days in Patients with Advanced Solid Tumors

Clinical cancer research, 2009-06, Vol.15 (12), p.4213-4219

2009

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From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely

Clinical cancer research, 2017-09, Vol.23 (17), p.4980-4991

2017

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Selective Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor ZD1839 Is Generally Well-Tolerated and Has Activity in Non–Small-Cell Lung Cancer and Other Solid Tumors: Results of a Phase I Trial

Journal of clinical oncology, 2002-09, Vol.20 (18), p.3815-3825

2002

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Clinical pharmacology profile of vorinostat, a histone deacetylase inhibitor

Cancer chemotherapy and pharmacology, 2013-09, Vol.72 (3), p.493-508

2013

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Mechanisms of resistance to topoisomerase I-targeting drugs

Oncogene, 2003-10, Vol.22 (47), p.7296-7304

2003

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Topors Functions as an E3 Ubiquitin Ligase with Specific E2 Enzymes and Ubiquitinates p53

The Journal of biological chemistry, 2004-08, Vol.279 (35), p.36440-36444

2004

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Adaptive phase 2/3 designs for oncology drug development – Time to hedge

Contemporary clinical trials, 2023-02, Vol.125, p.107047-107047, Article 107047

2023

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Pharmacokinetic/Pharmacodynamic Modeling and Simulation of Neutropenia during Phase I Development of Liposome-Entrapped Paclitaxel

Clinical cancer research, 2008-09, Vol.14 (18), p.5856-5863

2008

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Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors

Clinical cancer research, 2006-11, Vol.12 (21), p.6517-6522

2006

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Phase I Dose-Finding Study of Weekly Single-Agent Patupilone in Patients With Advanced Solid Tumors

Journal of clinical oncology, 2005-12, Vol.23 (36), p.9120-9129

2005

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A Study to Determine the Effects of Food and Multiple Dosing on the Pharmacokinetics of Vorinostat Given Orally to Patients with Advanced Cancer

Clinical cancer research, 2006-12, Vol.12 (23), p.7039-7045

2006

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A Biomarker-enriched, Randomized Phase II Trial of Adavosertib (AZD1775) Plus Paclitaxel and Carboplatin for Women with Platinum-sensitive TP53 -mutant Ovarian Cancer

Clinical cancer research, 2020-09, Vol.26 (18), p.4767-4776

2020

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The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development

Cancer discovery, 2011-06, Vol.1 (1), p.17-20

2011

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Reflecting on Merck’s I-O biomarker development journey

Immuno Oncology Insights, 2021-06, Vol.2 (3), p.115-121

Rubin, MD, Eric H Rubin, MD Eric H

2021

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Transcription-Dependent Degradation of Topoisomerase I-DNA Covalent Complexes

Molecular and Cellular Biology, 2003-04, Vol.23 (7), p.2341-2350

2003

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Challenges with Novel Clinical Trial Designs: Master Protocols

Clinical cancer research, 2019-04, Vol.25 (7), p.2049-2057

2019

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A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development

Contemporary clinical trials, 2018-01, Vol.64, p.238-242

2018

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Ubiquitination by TOPORS Regulates the Prostate Tumor Suppressor NKX3.1

The Journal of biological chemistry, 2008-02, Vol.283 (8), p.4834-4840

2008

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Finding the Right Dose for Cancer Therapeutics—Can We Do Better?

Clinical cancer research, 2010-02, Vol.16 (4), p.1085-1087

2010

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The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer

Journal of clinical oncology, 2016-10, Vol.34 (30), p.3638-3647

2016

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Drug development and clinical trials--the path to an approved cancer drug

Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors

Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy

Antitumor activity in RAS-driven tumors by blocking AKT and MEK

Epothilones: Mechanism of Action and Biologic Activity

Phase I Study of Eribulin Mesylate Administered Once Every 21 Days in Patients with Advanced Solid Tumors

From Famine to Feast: Developing Early-Phase Combination Immunotherapy Trials Wisely

Selective Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor ZD1839 Is Generally Well-Tolerated and Has Activity in Non–Small-Cell Lung Cancer and Other Solid Tumors: Results of a Phase I Trial

Clinical pharmacology profile of vorinostat, a histone deacetylase inhibitor

Mechanisms of resistance to topoisomerase I-targeting drugs

Topors Functions as an E3 Ubiquitin Ligase with Specific E2 Enzymes and Ubiquitinates p53

Adaptive phase 2/3 designs for oncology drug development – Time to hedge

Pharmacokinetic/Pharmacodynamic Modeling and Simulation of Neutropenia during Phase I Development of Liposome-Entrapped Paclitaxel

Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors

Phase I Dose-Finding Study of Weekly Single-Agent Patupilone in Patients With Advanced Solid Tumors

A Study to Determine the Effects of Food and Multiple Dosing on the Pharmacokinetics of Vorinostat Given Orally to Patients with Advanced Cancer

A Biomarker-enriched, Randomized Phase II Trial of Adavosertib (AZD1775) Plus Paclitaxel and Carboplatin for Women with Platinum-sensitive TP53 -mutant Ovarian Cancer

The BATTLE trial: a bold step toward improving the efficiency of biomarker-based drug development

Reflecting on Merck’s I-O biomarker development journey

Transcription-Dependent Degradation of Topoisomerase I-DNA Covalent Complexes

Challenges with Novel Clinical Trial Designs: Master Protocols

A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development

Ubiquitination by TOPORS Regulates the Prostate Tumor Suppressor NKX3.1

Finding the Right Dose for Cancer Therapeutics—Can We Do Better?

The BATTLE-2 Study: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer

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