AREA UNDER THE CURVE;
CARDIOTOXICITY;
DOSE RESPONSE;
DRUG DOSE REDUCTION;
DRUG EFFICACY;
DRUG SAFETY;
FOOD DRUG INTERACTION;
GASTROINTESTINAL TOXICITY;
HUMAN;
KIDNEY CANCER;
KIDNEY DISEASE;
LUNG CANCER;
MAXIMUM TOLERATED DOSE;
NEUROPATHY;
ONCOLOGY;
PHASE 1 CLINICAL TRIAL (TOPIC);
PHASE 2 CLINICAL TRIAL (TOPIC);
PRIORITY JOURNAL;
RANDOMIZED CONTROLLED TRIAL (TOPIC);
SHORT SURVEY;
ARTICLE;
DRUG APPROVAL;
METHODOLOGY;
MOLECULARLY TARGETED THERAPY;
ANTINEOPLASTIC AGENTS;
CLINICAL TRIALS, PHASE I AS TOPIC;
CLINICAL TRIALS, PHASE II AS TOPIC;
DRUG APPROVAL;
HUMANS;
MOLECULAR TARGETED THERAPY;
RESEARCH DESIGN;
Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international survey
Paoletti, X. et al. Defining dose-limiting toxicity for phase 1 trials of molecularly targeted agents: Results of a DLT-TARGETT international survey. Eur. J. Cancer 50, 2050-2056 (2014).
Dose-response information to support drug registration E4. ICH Harmonised Tripartite Guidline [online], http://www.ich.org/fileadmin/Public-Web-Site/ICH- Products/Guidelines/Efficacy/E4/Step4/E4-Guideline.pdf (1994).
Randomized phase II study of multiple dose levels of CCI 779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma
Atkins, M. B. et al. Randomized phase II study of multiple dose levels of CCI 779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J. Clin. Oncol. 22, 909-918 (2004).
A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer
Jonat, W. et al. A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate in postmenopausal patients with advanced breast cancer. Eur. J. Cancer 32A, 404-412 (1996).
FDA Center for Drug Evaluation and Research [online]
Ceritinib drug safety data. FDA Center for Drug Evaluation and Research [online], http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/ 205755Orig1s000SumR.pdf (2014).
FDA Center for Drug Evaluation and Research [online]
Ceritinib drug safety data summary review. FDA Center for Drug Evaluation and Research [online], http://www.accessdata.fda.gov/drugsatfda-docs/nda/2014/ 205755Orig1s000ClinPharmR.pdf (2014).
FDA Center for Drug Evaluation and Research [online]
Ceritinib clinical investigator financial disclosure review template. FDA Center for Drug Evaluation and Research [online], http://www.accessdata. fda.gov/drugsatfda-docs/nda/2014/205755Orig1s000MedR.pdf (2014).
The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP 690, 550 versus placebo
Kremer, J. M. et al. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP 690, 550 versus placebo. Arthritis Rheum. 60, 1895-1905 (2009