Randomised, Phase II study of selumetinib, an oral inhibitor of MEK, in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary …
MK Doherty, VC Tam, MG McNamara, R Jang… - British Journal of …, 2022 - nature.com
Abstract Introduction Cisplatin and gemcitabine (CisGem) are standard chemotherapy for
advanced biliary tract cancer (BTC). The MEK inhibitor selumetinib showed synergy with …
advanced biliary tract cancer (BTC). The MEK inhibitor selumetinib showed synergy with …
Melanoma: a model for testing new agents in combination therapies
PA Ascierto, HZ Streicher, M Sznol - Journal of Translational Medicine, 2010 - Springer
Abstract Treatment for both early and advanced melanoma has changed little since the
introduction of interferon and IL-2 in the early 1990s. Recent data from trials testing targeted …
introduction of interferon and IL-2 in the early 1990s. Recent data from trials testing targeted …
On the use of change in tumor size to predict survival in clinical oncology studies: toward a new paradigm to design and evaluate phase II studies
R Bruno, L Claret - Clinical Pharmacology & Therapeutics, 2009 - Wiley Online Library
Drug‐independent models that link biomarker response to clinical end points are critical to
support early (end of phase II) clinical decisions. In oncology, change in tumor size (a …
support early (end of phase II) clinical decisions. In oncology, change in tumor size (a …
Survival prediction in everolimus-treated patients with metastatic renal cell carcinoma incorporating tumor burden response in the RECORD-1 trial
A Stein, J Bellmunt, B Escudier, D Kim… - European urology, 2013 - Elsevier
Background The phase 3 RECORD-1 study demonstrated clinical benefit of everolimus over
placebo (median progression-free survival: 4.9 mo compared with 1.9 mo, p< 0.001) in …
placebo (median progression-free survival: 4.9 mo compared with 1.9 mo, p< 0.001) in …
The statistics of phase 0 trials
LV Rubinstein, SM Steinberg, S Kummar… - Statistics in …, 2010 - Wiley Online Library
The PD‐driven phase 0 trial is a new form, designed to be a first‐in‐man study, often of a
new agent, conducted to assess drug effect on a molecular target, by means of a …
new agent, conducted to assess drug effect on a molecular target, by means of a …
Exposure–response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection
JF Lu, E Rasmussen, BY Karlan, IB Vergote… - Cancer chemotherapy …, 2012 - Springer
Purpose To characterize exposure–response relationships of AMG 386 in a phase 2 study in
advanced ovarian cancer for the facilitation of dose selection in future studies. Methods A …
advanced ovarian cancer for the facilitation of dose selection in future studies. Methods A …
Tumor-specific activity of precision medicines in the NCI-MATCH trial
Abstract Purpose: National Cancer Institute Molecular Analysis for Therapy Choice (NCI-
MATCH) is a precision medicine basket trial designed to test the effectiveness of treating …
MATCH) is a precision medicine basket trial designed to test the effectiveness of treating …
Progression-free survival ratio as end point for phase II trials in advanced solid tumors
M Buyse, E Quinaux, A Hendlisz… - Journal of Clinical …, 2011 - ascopubs.org
TO THE EDITOR: Von Hoff et al1 have investigated the potential of molecular profiling for the
selection of treatments for patients with advanced solid tumors. These authors used the …
selection of treatments for patients with advanced solid tumors. These authors used the …
Making the investigational oncology pipeline more efficient and effective: are we headed in the right direction?
PM LoRusso, AB Anderson, SA Boerner… - Clinical Cancer …, 2010 - AACR
Advances in our knowledge of the molecular mechanisms involved in cancer biology have
contributed to an increase in novel target-specific oncology therapeutics. Unfortunately …
contributed to an increase in novel target-specific oncology therapeutics. Unfortunately …
Objective assessment of tumour response to therapy based on tumour growth kinetics
Background: Current standards for assessment of tumour response to therapy (a) categorise
therapeutic efficacy values, inappropriate for patient-specific and deterministic studies,(b) …
therapeutic efficacy values, inappropriate for patient-specific and deterministic studies,(b) …