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A Phase I study of intravenous PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors.
- Source :
-
Cancer Chemotherapy & Pharmacology . Jan2017, Vol. 79 Issue 1, p89-98. 10p. - Publication Year :
- 2017
-
Abstract
- <bold>Purpose: </bold>To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the intravenously administered pan-PI3K inhibitor copanlisib in Japanese patients with advanced or refractory solid tumors.<bold>Methods: </bold>A Phase I open-label study in Japanese patients with advanced or refractory solid tumors was carried out. Patients received a single intravenous dose of either copanlisib 0.4 mg/kg or copanlisib 0.8 mg/kg, dosed intermittently on days 1, 8, and 15 of a 28-day cycle. Safety was monitored throughout the study. Plasma copanlisib levels were measured for pharmacokinetic analysis.<bold>Results: </bold>Ten patients were enrolled and treated; three received copanlisib 0.4 mg/kg and seven received copanlisib 0.8 mg/kg. Overall, median duration of treatment was 6.2 weeks. No patients treated at 0.4 mg/kg experienced a dose-limiting toxicity, and the maximum tolerated dose in Japanese patients was determined to be 0.8 mg/kg. Adverse events were recorded in all ten patients; the most common were hyperglycemia, hypertension, and constipation. Copanlisib pharmacokinetic exposures displayed near dose-proportionality, with no accumulation. No patients achieved a complete or partial response, and disease control rate was 40.0%.<bold>Conclusions: </bold>Copanlisib was well tolerated in Japanese patients with advanced or refractory solid tumors, and the maximum tolerated dose was determined to be 0.8 mg/kg. Copanlisib demonstrated near dose-proportional pharmacokinetics and preliminary disease control, warranting further investigation.<bold>Clinical Trial Registration Number: </bold>NCT01404390. [ABSTRACT FROM AUTHOR]
- Subjects :
- *PHOSPHATIDYLINOSITOL 3-kinases
*TUMOR treatment
*TUMORS
*DRUG administration
*PHARMACOKINETICS
*CLINICAL trials
*PATIENTS
*ANTINEOPLASTIC agents
*COMPARATIVE studies
*DRUG dosage
*DRUG toxicity
*HETEROCYCLIC compounds
*RESEARCH methodology
*MEDICAL cooperation
*PHOSPHOTRANSFERASES
*RESEARCH
*EVALUATION research
*CHEMICAL inhibitors
Subjects
Details
- Language :
- English
- ISSN :
- 03445704
- Volume :
- 79
- Issue :
- 1
- Database :
- Academic Search Index
- Journal :
- Cancer Chemotherapy & Pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 120643393
- Full Text :
- https://doi.org/10.1007/s00280-016-3198-0