Molecular targets and cancer therapeutics: discovery, development and clinical validation

BA Teicher - Drug Resistance Updates, 2000 - Elsevier
… There is no doubt that the general principles of cancer therapeutics established over the
past 50 years remain valid. Combination treatment regimens covering multiple targets should …

Pharmacodynamic biomarkers for molecular cancer therapeutics

D Sarker, P Workman - Advances in cancer research, 2006 - Elsevier
… ), erlotinib (Tarceva), bevacizumab (Avastin), cetuximab (Erbitux), sorafenib (Nexavar),
and sunitinib (Sutent) have provided clinical validation for this molecularly targeted approach. …

Efficient, adaptive clinical validation of predictive biomarkers in cancer therapeutic development

RA Beckman, C Chen - … in Cancer Biomarkers: From biochemistry to clinic …, 2015 - Springer
… be clinically validated by the Phase 3 result. … clinical validation defines these rules for the
large number of moves and pieces which make up the very serious strategic contest of cancer

Validation of biomarkers to predict response to immunotherapy in cancer: volume II—clinical validation and regulatory considerations

KK Dobbin, A Cesano, J Alvarez, R Hawtin… - … of cancer, 2016 - Springer
therapeutic approaches. In order to be applicable in a … focus is on the clinical validation,
validation of clinical utility and … Specifically, knowledge about the challenges to clinical validation

New approaches to molecular cancer therapeutics

I Collins, P Workman - Nature chemical biology, 2006 - nature.com
… A major expectation for targeted molecular cancer therapeutics is that they show good …
Although it requires further experimental validation, this concept proposes that cancer cells …

[HTML][HTML] Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges

SJ Mandrekar, DJ Sargent - Journal of Clinical Oncology, 2009 - ncbi.nlm.nih.gov
… are likely to have a favorable clinical outcome, such as improved … focus on clinical trial designs
for predictive marker validation, … the rapid clinical validation of biomarker-guided therapy. …

Meaningful prevention of breast cancer metastasis: candidate therapeutics, preclinical validation, and clinical trial concerns

AS Zimmer, PS Steeg - Journal of Molecular Medicine, 2015 - Springer
… and clinical metastasis prevention data for FDA-approved breast cancer therapeutics … been
reported in the preclinical development and validation of metastasis clinical strategies. Many …

Common pitfalls in preclinical cancer target validation

WG Kaelin Jr - Nature Reviews Cancer, 2017 - nature.com
… the fact that the issue in cancer therapeutics is not whether a target is important or essential
in normal cells, but whether the target is more important in cancer cells than it is in normal …

Patient-Driven Discovery, Therapeutic Targeting, and Post-Clinical Validation of a Novel AKT1 Fusion–Driven Cancer

EK Slotkin, D Diolaiti, NN Shukla, FS Dela Cruz… - Cancer discovery, 2019 - AACR
… , was an oncogenic driver, and could be therapeutically targeted with clinical benefit. Post-clinical
validation using patient-derived model systems corroborated these findings, confirmed …

The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute …

L Seymour, SP Ivy, D Sargent, D Spriggs, L Baker… - Clinical Cancer …, 2010 - AACR
… In most instances, the biomarker is not clinically validated as a predictive marker (of efficacy)
early in the development of a new agent (ie, at the time of the phase II trial). The IDSC's …