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 …
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. …
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 …
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 …
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 …
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. …
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 …
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 …
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 …
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 …
… 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 …
early in the development of a new agent (ie, at the time of the phase II trial). The IDSC's …
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