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Clinical Trial 18521
Interventions:Abiraterone acetate; Dexamethasone; KPT-8602; Zytiga (Abiraterone acetate)
Study Type: Treatment
Phase of Study: Phase I/II
- Jingsong Zhang
A Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE)Compound KPT-8602 in Patients with Relapsed/Refractory Cancer Indications
The purpose of this study is to find out the highest dose of KPT-8602 that can be given safely, any side-effects that it may cause, how the body affects the study drug concentrations in the blood (pharmacokinetics), the effects of the study drug on the body (pharmacodynamics) and to gain some information on its effectiveness in treating multiple myeloma.
Primary: - To determine the MTD within the tested dose range for KPT-8602 in RRMM. - To determine the RP2D for KPT-8602 in relapsed/refractory MM, CRC, mCRPC, and higher risk MDS. - To evaluate the safety and tolerability, including DLTs of KPT-8602. - To determine preliminary evidence of anti-tumor activity of KPT-8602 in patients with relapsed/refractory MM, CRC (KRAS wild-type and KRAS mutant), mCRPC, and higher risk MDS according to assessment by any or all of the following: ORR and duration of response (DOR); Progression-free survival (PFS); Overall survival (OS); CBR and duration of CBR; Disease control rate (DCR) and duration of DCR. Secondary: - To determine the PK of KPT-8602, maximum plasma concentration, area under the curve, time-to-peak plasma concentration, terminal half-life, volume of distribution, and clearance rate. Exploratory: - To evaluate correlations of KPT-8602 response with molecular markers relevant to eachtumor type; - To evaluate the PDn and pharmacogenomic correlations of KPT-8602; - To evaluate target engagement of KPT-8602; - To identify possible mechanisms of resistance to KPT-8602.