Clinical Trials Directory

Trials / Completed

CompletedNCT02649790

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications

A Phase 1/2 Open-Label Study of the Safety, Tolerability and Efficacy of the Selective Inhibitor of Nuclear Export (SINE) Compound Eltanexor (KPT-8602) in Patients With Newly Diagnosed and Relapsed/Refractory Cancer Indications

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
277 (estimated)
Sponsor
Karyopharm Therapeutics Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a first-in-human, multi-center, open-label clinical study with separate dose escalation (Phase 1) and expansion (Phase 2) stages to assess preliminary safety, tolerability, and efficacy of the second generation oral XPO1 inhibitor KPT-8602 in participants with relapsed/refractory multiple myeloma (MM), metastatic colorectal cancer (mCRC), metastatic castration resistant prostate cancer (mCRPC), higher risk myelodysplastic syndrome (HRMDS), acute myeloid leukemia (AML) and newly diagnosed intermediate/high-risk MDS. Dose escalation and dose expansion may be included for all parts of the study as determined by ongoing study results.

Conditions

Interventions

TypeNameDescription
DRUGKPT-8602Participants will receive KPT-8602 oral tablets.
DRUGASTX727ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine.
DRUGDexamethasoneParticipants will receive dexamethasone oral tablets.

Timeline

Start date
2016-01-01
Primary completion
2024-08-31
Completion
2024-12-23
First posted
2016-01-07
Last updated
2025-03-19

Locations

46 sites across 5 countries: United States, Canada, China, France, Spain

Regulatory

Source: ClinicalTrials.gov record NCT02649790. Inclusion in this directory is not an endorsement.