Studying navitoclax, a targeted anticancer drug, in healthy volunteers - Ethical considerations and risk/benefit assessments and management

Anticancer Research

Volumn 34, Issue 7, 2014, Pages 3739-3746

  Xiong, Hao ^a   Pradhan, Rajendra S ^b   Nada, Adel ^c   Krivoshik, Andrew P ^d   Holen, Kyle D ^a   Rhodes, James W ^a   Gordon, Gary B ^a   Humerickhouse, Rod ^a   Awni, Walid M ^a  

^a ABBVIE INC   (United States)

^b ALEXION PHARMACEUTICALS   (United States)

^c Caladrius Biosciences   (United States)

^d ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

Author keywords

Bcl 2 inhibitor; Healthy volunteers; Navitoclax; Phase 1 clinical trials; Safety risk evaluation and management

Indexed keywords

NAVITOCLAX; ANILINE DERIVATIVE; ANTINEOPLASTIC AGENT; SULFONAMIDE;

ADULT; ANIMAL EXPERIMENT; ANIMAL MODEL; AREA UNDER THE CURVE; ARTICLE; BLEEDING; CANCER PATIENT; CANCER RISK; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL STUDY; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; ELIMINATION HALF-LIFE; FEASIBILITY STUDY; FEMALE; FERTILITY; FOOD; HUMAN; HUMAN CELL; LYMPHOCYTE; LYMPHOCYTOPENIA; LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; MEDICAL ETHICS; MULTICENTER STUDY; NONHUMAN; NORMAL HUMAN; OPPORTUNISTIC INFECTION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RAT; REPRODUCTIVE TOXICITY; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SOLID TUMOR; TESTIS DISEASE; THROMBOCYTE; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; BCL-2 INHIBITOR; BIOAVAILABILITY; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; ETHICS; FOOD DRUG INTERACTION; MALE; METABOLISM; METHODOLOGY; NEOPLASM; ORAL DRUG ADMINISTRATION; PHARMACEUTICS; PHASE 1 CLINICAL TRIALS; RISK ASSESSMENT; SAFETY RISK EVALUATION AND MANAGEMENT;

BCL-2 INHIBITOR; HEALTHY VOLUNTEERS; NAVITOCLAX; PHASE 1 CLINICAL TRIALS; SAFETY RISK EVALUATION AND MANAGEMENT;

ADMINISTRATION, ORAL; ADULT; ANILINE COMPOUNDS; ANTINEOPLASTIC AGENTS; BIOLOGICAL AVAILABILITY; BIOPHARMACEUTICS; COHORT STUDIES; CROSS-OVER STUDIES; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; NEOPLASMS; RISK ASSESSMENT; SULFONAMIDES;

EID: 84906311349     PISSN: 02507005     EISSN: 17917530     Source Type: Journal    
DOI: None     Document Type: Article

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