Predictors for establishing recommended phase 2 doses: Analysis of 320 dose-seeking oncology phase 1 trials

Investigational New Drugs

Volumn 30, Issue 2, 2012, Pages 653-661

  Penel, Nicolas ^a,b   Duhamel, Alain ^b   Adenis, Antoine ^a   Devos, Patrick ^b   Isambert, Nicolas ^c,d   Clisant, Stéphanie ^a   Bonneterre, Jacques ^a  

^a CENTRE OSCAR LAMBRET   (France)

^b UNIV LILLE   (France)

^c CENTRE GEORGES FRANÇOIS LECLERC   (France)

^d INSERM   (France)

Author keywords

CHAID; Dose finding; Methodology; Phase 1 trial

Indexed keywords

BEVACIZUMAB; CYTOTOXIC AGENT; NEW DRUG; RITUXIMAB; SORAFENIB; TRASTUZUMAB; ANTINEOPLASTIC AGENT;

ALGORITHM; ARTICLE; BLEEDING; CONFIDENCE INTERVAL; DATA ANALYSIS; DRUG DOSE; DRUG DOSE ESCALATION; ENTEROCUTANEOUS FISTULA; HUMAN; LOGISTIC REGRESSION ANALYSIS; MAXIMUM TOLERATED DOSE; METHODOLOGY; MOLECULARLY TARGETED THERAPY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PREDICTION; PRIORITY JOURNAL; PUBLICATION; RECOMMENDED DRUG DOSE; RECOMMENDED PHASE 2 DOSE; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; STARTING DOSE; EVIDENCE BASED MEDICINE; RISK; STATISTICAL MODEL; TREATMENT OUTCOME;

ALGORITHMS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CONFIDENCE INTERVALS; EVIDENCE-BASED MEDICINE; HUMANS; LOGISTIC MODELS; MAXIMUM TOLERATED DOSE; MOLECULAR TARGETED THERAPY; ODDS RATIO; RETROSPECTIVE STUDIES; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME;

EID: 84862269362     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-010-9574-4     Document Type: Article

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