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Eltanexor + Inqovi for Myelodysplastic Syndrome

Phase 1 & 2

Recruiting

Led By Steven Z Pavletic, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each cycle (bloods), cycle 2 and 6 during treatment and every 3-6 months (bloods and bone marrow)

Awards & highlights

Study Summary

This trial tests a study drug to treat high-risk MDS, a form of bone marrow disease. Participants will take two tablets for at least 6 cycles and have follow-up visits for 8 years.

Who is the study for?

Adults over 18 with high-risk Myelodysplastic Syndromes (MDS) that didn't improve after treatment can join. They need to be fairly active, have good organ function, and not pregnant or breastfeeding. Participants must agree to use birth control and have no recent growth factor treatments or uncontrolled illnesses.Check my eligibility

What is being tested?

The trial is testing Eltanexor (KPT-8602) combined with Inqovi (Decitabine-Cedazuridine), both oral tablets for MDS. Over at least six 28-day cycles, participants take these drugs at home and visit the clinic regularly for exams and tests like blood work and bone marrow biopsies.See study design

What are the potential side effects?

Possible side effects of KPT-8602 and Inqovi include digestive issues, changes in blood cell counts leading to anemia or infection risk, liver problems, fatigue, heart rhythm changes. Specific side effects will vary by individual.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each cycle (bloods), cycle 2 and 6 during treatment and every 3-6 months (bloods and bone marrow)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each cycle (bloods), cycle 2 and 6 during treatment and every 3-6 months (bloods and bone marrow)

This trial's timeline: 3 weeks for screening, Varies for treatment, and each cycle (bloods), cycle 2 and 6 during treatment and every 3-6 months (bloods and bone marrow) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: To determine the recommended phase 2 dose (RP2D) of KPT-8602 in combination with Inqovi in adult participants with with higher-MDS

Phase 2: To determine the overall response rate (ORR) of KPT-8602 in combination with Inqovi in adult participants with with higher-MDS

Secondary outcome measures

Phase 1: To characterize the PK properties of KPT-8602 in combination with Inqovi in MDS participants

Phase 2: To further evaluate the PK properties and safety of KPT-8602 in combination with Inqovi in MDS participants

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II- Dose expansion for HR-MDSExperimental Treatment2 Interventions

Inqovi for 5 days, followed by RP2D/Phase II dose of KPT-8602

Group II: Phase I- Dose escalation of KPT-8602 for HR-MDSExperimental Treatment2 Interventions

Inqovi for 5 days, followed by escalating doses of KPT-8602

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,926,361 Total Patients Enrolled

Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)

15 Previous Clinical Trials

3,723 Total Patients Enrolled

Media Library

Myelodysplastic Syndrome Research Study Groups: Phase I- Dose escalation of KPT-8602 for HR-MDS, Phase II- Dose expansion for HR-MDS

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial only serve individuals who are over 80 years old?

"According to the enrollment criteria, adults aged 18 and above are qualified for participation in this trial; there is no upper age limit."

Answered by AI

Are there any unoccupied slots available for participants in this research?

"According to clinicaltrials.gov, the enrollment period for this medical trial has closed as of June 28th 2023. Fortunately, there are 1,648 other trials that are still recruiting participants at this present time."

Answered by AI

Do I meet the qualifications necessary to take part in this research experiment?

"Eligibility criteria for this clinical trial necessitate that patients present with myelodysplastic syndrome and are between 18 to 120 years old. Currently, 80 participants can take part in the research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Eltanexor (KPT-8602) With Inqovi (Decitabine-Cedazuridine) in High-Risk Myelodysplastic Syndromes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918055.