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Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes

NCT05918055 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-12-02

Study results available
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Summary

Background:

Myelodysplastic syndromes (MDS) are diseases that affect the bone marrow. They can inhibit the blood formation process and reduce blood cell counts. High-risk MDS can lead to leukemia. People with high-risk MDS have a low survival rate. Better treatments are needed.

Objective:

To test a study drug Eltanexor (KPT-8602), combined with another drug (Inqovi), in people with MDS.

Eligibility:

Adults aged 18 years and older with high-risk MDS that did not respond to treatment.

Design:

Participants will be screened. They will have a physical exam. They will have blood and urine tests and tests of their heart function. They may have a bone marrow biopsy: Their hip will be numbed; then a needle will be inserted to draw out a sample of soft tissue from inside the bone. They will answer questions about their quality of life. Genetic tests may be performed.

KPT-8602 and Inqovi are both tablets taken by mouth. Participants will take these drugs at home on a 28-day cycle. They will take Inqovi once a day on days 1 to 5. They will take KPT-8602 on a schedule assigned by the researcher. Participants will be given a drug diary to record each dose.

Participants will visit the clinic for an exam at least once in each cycle. Some tests, including the bone marrow biopsy, may be repeated.

Participants will continue treatment for at least 6 cycles. If their disease improves, they may continue taking the drugs after 6 cycles.

Participants will have follow-up visits at the clinic for about 8 years.

Conditions

Interventions

DRUG

KPT-8602

5-10 mg by mouth (PO) daily for 10-14 days based on dose level

DRUG

Inqovi

Inqovi will be administered via oral route once daily on Days 1-5 of each treatment cycle, according to guidelines outlined in the Food and Drug Administration (FDA) product label.

PROCEDURE

Bone marrow aspirate

Screening (if necessary), baseline (30 days prior to treatment start), and Cycle 1, Day 28 (phase I only).

PROCEDURE

Bone marrow biopsy

Screening (if necessary), baseline (30 days prior to treatment start), and Cycle 1, Day 28 (phase I only).

DIAGNOSTIC_TEST

ECG

Screening and baseline. Cycle 1, Day 1 and Cycle 1, Day 15 (2 hours post dose that day +/- 20 minutes).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Najla El Jurdi, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-03-10
Completion
2025-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05918055 on ClinicalTrials.gov