An open-label, dose escalation, phase I study to evaluate the tolerability, safety and pharmacokinetics of afuresertib monotherapy and in combination with bortezomib and dexamethasone in Japanese relapsed multiple myeloma patients.
Phase 1
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2080222524
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Japanese Relapsed Multiple Myeloma Patients
Exclusion Criteria
Chemotherapy, radiotherapy, immunotherapy or other anti-myeloma therapy within 28 days prior to enrolment. In addition, any toxicity (except alopecia) should be recovered to <=Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.0.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Number of subjects with Dose-limiting toxicities (DLTs) when afuresertib is given as monotherapy
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Safety and Pharmacokinetics of Afuresertib Monotherapy in Japanese Relapsed Multiple Myeloma Patients