Dose selection for the investigational anticancer agent alisertib (MLN8237): Pharmacokinetics, pharmacodynamics, and exposure-safety relationships

Journal of Clinical Pharmacology

Volumn 55, Issue 3, 2015, Pages 336-347

  Venkatakrishnan, Karthik ^a   Zhou, Xiaofei ^a   Ecsedy, Jeffrey ^a   Mould, Diane R ^b   Liu, Hua ^a   Danaee, Hadi ^a   Fingert, Howard ^a   Kleinfield, Robert ^a   Milton, Ashley ^a  

^a TAKEDA PHARMACEUTICAL COMPANY LIMITED   (Japan)

^b Projections Research Inc   (United States)

Author keywords

alisertib; Aurora A kinase; dose; MLN8237; oncology

Indexed keywords

ALISERTIB; ANTINEOPLASTIC AGENT; AURKA PROTEIN, HUMAN; AURORA A KINASE; AZEPINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE;

ABSORPTION HALF-LIFE; ABSORPTION RATE CONSTANT; ADULT; AREA UNDER THE CURVE; ARTICLE; CANCER PATIENT; CENTRAL VOLUME OF DISTRIBUTION; COMPARATIVE STUDY; DIARRHEA; DOSAGE SCHEDULE COMPARISON; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EXPOSURE; DRUG SAFETY; HUMAN; MAJOR CLINICAL STUDY; MALIGNANT NEOPLASTIC DISEASE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MITOSIS; MITOSIS INDEX; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PERIPHERAL VOLUME OF DISTRIBUTION; PHARMACOKINETIC PARAMETERS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; QUANTITATIVE ANALYSIS; SINGLE DRUG DOSE; SOMNOLENCE; STOMATITIS; THROMBOCYTOPENIA; ANTAGONISTS AND INHIBITORS; BIOLOGICAL MODEL; DOSE CALCULATION; DOSE RESPONSE; METABOLISM; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC);

ADMINISTRATION, ORAL; ANTINEOPLASTIC AGENTS; AURORA KINASE A; AZEPINES; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG DOSAGE CALCULATIONS; HUMANS; MAXIMUM TOLERATED DOSE; MODELS, BIOLOGICAL; PROTEIN KINASE INHIBITORS; PYRIMIDINES;

EID: 84940985215     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.410     Document Type: Article

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