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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
No Placebo-Only Group
Summary
This trial is testing a new drug combination (KPT-8602 and Inqovi) for adults with severe blood disease (high-risk MDS) who haven't improved with standard treatments. Inqovi stops cancer cell growth, while KPT-8602 blocks a protein that helps cancer cells survive.
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.
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.
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myelodysplastic Syndrome (MDS) include Selective Inhibitors of Nuclear Export (SINE) and hypomethylating agents. SINE, such as KPT-8602, work by inhibiting the export of tumor suppressor proteins from the nucleus, thereby promoting apoptosis of malignant cells.
Hypomethylating agents like Decitabine, which is part of Inqovi, inhibit DNA methylation, leading to the reactivation of tumor suppressor genes and induction of cell differentiation and apoptosis. Cedazuridine, combined with Decitabine in Inqovi, increases the bioavailability of Decitabine by inhibiting its degradation.
These mechanisms are crucial for MDS patients as they target the underlying genetic and epigenetic abnormalities, potentially improving blood cell counts and reducing the progression to acute myeloid leukemia.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,955 Previous Clinical Trials
41,111,881 Total Patients Enrolled
Steven Z Pavletic, M.D.Principal InvestigatorNational Cancer Institute (NCI)
15 Previous Clinical Trials
3,475 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Phase I- Dose escalation of KPT-8602 for HR-MDS
- Group 2: Phase II- Dose expansion for HR-MDS