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

NCT02649790 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2025-03-19

No results posted yet for this study

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

  • Relapsed/Refractory Multiple Myeloma (RRMM)
  • Metastatic Colorectal Cancer (mCRC)
  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Higher-Risk Myelodysplastic Syndrome (HR-MDS)
  • Acute Myeloid Leukemia (AML)
  • Newly Diagnosed Intermediate/High-Risk MDS

Interventions

DRUG

KPT-8602

Participants will receive KPT-8602 oral tablets.

DRUG

ASTX727

ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine.

DRUG

Dexamethasone

Participants will receive dexamethasone oral tablets.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2024-08-31
Completion
2024-12-23
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649790 on ClinicalTrials.gov