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XPO1 inhibitor

KPT-8602 for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Research Sponsored by Karyopharm Therapeutics Inc

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Adequate renal function: estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) × Mass (kg)/(72 × creatinine mg/dL); multiply by 0.85 if female

Must not have

Uncontrolled active severe systemic infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1

Female participants who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess the safety, tolerability, and preliminary efficacy of KPT-8602, an oral XPO1 inhibitor, in patients with relapsed/refractory multiple myeloma, metastatic colorectal cancer, metastatic castration resistant prostate cancer, higher risk myelodysplastic syndrome, acute myeloid leukemia, and newly diagnosed intermediate/high-risk MDS.

Who is the study for?

Adults over 18 with certain relapsed/refractory cancers (like multiple myeloma, colorectal cancer) can join. They need good kidney and liver function, must follow contraception rules based on their condition, and agree to protocol requirements like biopsies. Those with brain metastasis, recent major surgery, severe infections or heart issues cannot participate.

What is being tested?

The trial is testing KPT-8602's safety and effectiveness in patients with specific advanced cancers. It includes a dose escalation phase to find the right amount of drug that's safe and a dose expansion phase to see how well it works at that dose.

What are the potential side effects?

Possible side effects may include digestive issues due to gastrointestinal tract involvement, blood disorders from bone marrow suppression common in cancer treatments, liver problems indicated by changes in enzyme levels, fatigue often seen with systemic therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidneys work well enough, based on a specific calculation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed strong IV drugs for a severe infection in the last week.

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I am not pregnant or breastfeeding.

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I have brain metastasis causing symptoms.

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I am willing to follow the study rules and provide samples for testing.

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I do not have stomach or intestine problems that could affect medicine absorption.

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I have heart problems that affect my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: Part H: AML Maintenance Therapy- KPT-8602 single agentExperimental Treatment1 Intervention

Participants with high-risk acute myeloid leukemia (AML) prior to transplant will be enrolled to receive maintenance therapy with KPT-8602 post-allogeneic stem cell transplantation. The dose for KPT-8602 will be 10 mg (RP2D from Part F) oral, to be administered once daily from Day 1 to Day 21 (Weeks 1 to 3) on a 28-day cycle.

Group II: Part G: Newly Diagnosed Intermediate/High-Risk MDS -KPT-8602 with ASTX727Experimental Treatment2 Interventions

Participants will receive KPT-8602 once daily at escalated doses. The starting dose for KPT-8602 is 5 mg orally once daily from Day 8 to Day 28 (Weeks 2 to 4) on a 28-day cycle in combination with ASTX727.

Group III: Part F: High-risk Myelodysplastic Syndrome (MDS)- KPT-8602 single agentExperimental Treatment1 Intervention

Participants were treated with KPT-8602 at a dose and schedule that had been cleared in Part A. In select cases (for example, participants achieving stable disease \[SD\], hematological improvement \[HI\], partial response \[PR\] and tolerating treatment, etc.), the dose may be escalated 1 level based on safety and efficacy considerations (completed).

Group IV: Part F Phase 2: RR High-risk MDS- KPT-8602 single agentExperimental Treatment1 Intervention

Participants will be enrolled at recommended Phase 2 doses (RP2D) of 10 mg daily on Days 1 to 5 of each week, in a dose expansion, based upon the results from the Phase 1 portion of Part F.

Group V: Part E: mCRPC- KPT-8602 with abiraterone and corticosteroidsExperimental Treatment1 Intervention

Participants were treated with KPT-8602 at a dose and schedule that had been cleared in Part A in combination with abiraterone and corticosteroids. Participants continued to receive the dose and schedule of abiraterone and corticosteroids that they were receiving at the time of enrollment (completed).

Group VI: Part D: mCRPC- KPT-8602 single agentExperimental Treatment1 Intervention

Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed).

Group VII: Part C: CRC- KPT-8602 single agentExperimental Treatment1 Intervention

Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed).

Group VIII: Part B: RRMM- KPT-8602 with low-dose dexamethasone; QDx5/weekExperimental Treatment2 Interventions

Participants received KPT-8602 for 5 consecutive days (QDx5/week) in combination with low dose dexamethasone (20 milligram \[mg\] on Days 1, 3, 8, 10, 15, 17, 22, and 24 of each 28-day cycle) (completed).

Group IX: Part A2: RRMM- KPT-8602 single agent; QoDx3/weekExperimental Treatment1 Intervention

Participants received KPT-8602 once daily for 3 days per week (QoDx3/week). The starting dose for Part A2 will be informed by Part A1 (completed).

Group X: Part A1: RRMM- KPT-8602 single agent; QoDx5/weekExperimental Treatment1 Intervention

Participants received KPT-8602 once daily for 5 days per week (QDx5/week) at escalated doses (completed).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASTX727

2018

Completed Phase 3

~270