Warning: Undefined array key "mm" in /www/wwwroot/www.ai-bt.com/si.php on line 10 Deprecated: trim(): Passing null to parameter #1 ($string) of type string is deprecated in /www/wwwroot/www.ai-bt.com/si.php on line 10 Phase III clinical trials that integrate treatment and biomarker evaluation.

Literature DB >> 23569306

Phase III clinical trials that integrate treatment and biomarker evaluation.

Boris Freidlin¹, Zhuoxin Sun, Robert Gray, Edward L Korn.

Abstract

Mesh：

Substances：
Biomarkers, Tumor

Year: 2013 PMID： 23569306 PMCID： PMC3753704 DOI： 10.1200/JCO.2012.48.3826

Source DB: PubMed Journal: J Clin Oncol ISSN： 0732-183X Impact factor: 44.544

× No keyword cloud information.

14 in total

1. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.

Authors: Jean-Yves Douillard; Salvatore Siena; James Cassidy; Josep Tabernero; Ronald Burkes; Mario Barugel; Yves Humblet; György Bodoky; David Cunningham; Jacek Jassem; Fernando Rivera; Ilona Kocákova; Paul Ruff; Maria Błasińska-Morawiec; Martin Šmakal; Jean-Luc Canon; Mark Rother; Kelly S Oliner; Michael Wolf; Jennifer Gansert
Journal: J Clin Oncol Date: 2010-10-04 Impact factor: 44.544

2. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer.

Authors: Marc Peeters; Timothy Jay Price; Andrés Cervantes; Alberto F Sobrero; Michel Ducreux; Yevhen Hotko; Thierry André; Emily Chan; Florian Lordick; Cornelis J A Punt; Andrew H Strickland; Gregory Wilson; Tudor-Eliade Ciuleanu; Laslo Roman; Eric Van Cutsem; Valentina Tzekova; Simon Collins; Kelly S Oliner; Alan Rong; Jennifer Gansert
Journal: J Clin Oncol Date: 2010-10-04 Impact factor: 44.544

3. Testing in a Prespecified Subgroup and the Intent-to-Treat Population.

Authors: Mark D Rothmann; Jenny J Zhang; Laura Lu; Thomas R Fleming
Journal: Drug Inf J Date: 2012-03-01

4. Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.

Authors: Mary W Redman; John J Crowley; Roy S Herbst; Fred R Hirsch; David R Gandara
Journal: Clin Cancer Res Date: 2012-05-16 Impact factor: 12.531

5. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients.

Authors: Boris Freidlin; Richard Simon
Journal: Clin Cancer Res Date: 2005-11-01 Impact factor: 12.531

6. Randomized phase II trial designs with biomarkers.

Authors: Boris Freidlin; Lisa M McShane; Mei-Yin C Polley; Edward L Korn
Journal: J Clin Oncol Date: 2012-08-06 Impact factor: 44.544

7. Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer.

Authors: Wolfram Brugger; Nadja Triller; Maria Blasinska-Morawiec; Stefan Curescu; Raimundas Sakalauskas; Georgy Moiseevich Manikhas; Julien Mazieres; Renaud Whittom; Carol Ward; Karen Mayne; Kerstin Trunzer; Federico Cappuzzo
Journal: J Clin Oncol Date: 2011-10-03 Impact factor: 44.544

8. Clinical trials for predictive medicine.

Authors: Richard Simon
Journal: Stat Med Date: 2012-06-19 Impact factor: 2.373

9. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1.

Authors: Giorgio V Scagliotti; Ihor Vynnychenko; Keunchil Park; Yukito Ichinose; Kaoru Kubota; Fiona Blackhall; Robert Pirker; Rinat Galiulin; Tudor-Eliade Ciuleanu; Oleksandr Sydorenko; Mircea Dediu; Zsolt Papai-Szekely; Natividad Martinez Banaclocha; Sheryl McCoy; Bin Yao; Yong-Jiang Hei; Francesco Galimi; David R Spigel
Journal: J Clin Oncol Date: 2012-07-02 Impact factor: 44.544

10. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer.

Authors: Stephen Johnston; John Pippen; Xavier Pivot; Mikhail Lichinitser; Saeed Sadeghi; Veronique Dieras; Henry Leonidas Gomez; Gilles Romieu; Alexey Manikhas; M John Kennedy; Michael F Press; Julie Maltzman; Allison Florance; Lisa O'Rourke; Cristina Oliva; Steven Stein; Mark Pegram
Journal: J Clin Oncol Date: 2009-09-28 Impact factor: 44.544

14 in total

Phase III clinical trials that integrate treatment and biomarker evaluation.

1. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study.

2. Randomized phase III study of panitumumab with fluorouracil, leucovorin, and irinotecan (FOLFIRI) compared with FOLFIRI alone as second-line treatment in patients with metastatic colorectal cancer.

3. Testing in a Prespecified Subgroup and the Intent-to-Treat Population.

4. Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.

5. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients.

6. Randomized phase II trial designs with biomarkers.

7. Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer.

8. Clinical trials for predictive medicine.

9. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1.

10. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer.

1. Statistical and practical considerations for clinical evaluation of predictive biomarkers.

2. Precision tyrosine kinase inhibitor dosing in chronic myeloid leukemia?

Review 3. Phase III Precision Medicine Clinical Trial Designs That Integrate Treatment and Biomarker Evaluation.

Review 4. Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations.

Review 5. Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Review 6. Biomarker enrichment strategies: matching trial design to biomarker credentials.

7. The Challenge for Development of Valuable Immuno-oncology Biomarkers.

Review 8. Accelerating Therapeutic Development through Innovative Trial Design in Colorectal Cancer.

Review 9. Drug-diagnostics co-development in oncology.

10. Evaluating many treatments and biomarkers in oncology: a new design.