A novel Phase I/IIa design for early phase oncology studies and its application in the evaluation of MK-0752 in pancreatic cancer

Statistics in Medicine

Volumn 31, Issue 18, 2012, Pages 1931-1943

  Whitehead, John ^a   Thygesen, Helene ^a   Jaki, Thomas ^a   Davies, Scot ^b   Halford, Sarah ^b   Turner, Helen ^b   Cook, Natalie ^b   Jodrell, Duncan ^b,c  

^a LANCASTER UNIVERSITY   (United Kingdom)

^b IMPERIAL CANCER RESEARCH FUND   (United Kingdom)

^c UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

Adaptive design; Bayesian procedure; Combination therapies; Dose finding; Pancreatic cancer; PhaseI II design

Indexed keywords

GEMCITABINE; MK 0752;

ARTICLE; BAYES THEOREM; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; LOW DRUG DOSE; MAXIMUM TOLERATED DOSE; MULTIPLE CYCLE TREATMENT; OPTIMAL DRUG DOSE; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RISK ASSESSMENT; RISK FACTOR; STATISTICAL DISTRIBUTION; STATISTICAL MODEL; STUDY DESIGN; SURVIVAL RATE; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BAYES THEOREM; BENZENE DERIVATIVES; CLINICAL TRIALS, PHASE II AS TOPIC; COMPUTER SIMULATION; DEOXYCYTIDINE; HUMANS; MODELS, STATISTICAL; PANCREATIC NEOPLASMS; PROPIONATES; RESEARCH DESIGN; SAMPLE SIZE; SULFONES;

EID: 84864022490     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5331     Document Type: Article

References (5)

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