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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 belowSelect...
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:Select...
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.
Select...
I have brain metastasis causing symptoms.
Select...
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
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
Dexamethasone
2007
Completed Phase 4
~2650
Find a Location
Who is running the clinical trial?
Karyopharm Therapeutics IncLead Sponsor
88 Previous Clinical Trials
7,296 Total Patients Enrolled
Jatin Shah, MDStudy DirectorKaryopharm Therapeutics Inc
5 Previous Clinical Trials
681 Total Patients Enrolled
Eric Sbar VP of Clinical Development, DOStudy DirectorKaryopharm Therapeutics Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't needed strong IV drugs for a severe infection in the last week.You have a history of HIV or active hepatitis A, B, or C infection.I have not had major surgery in the last 4 weeks.My liver is functioning within the required limits for the trial.I am not pregnant or breastfeeding.I have no other cancers that could affect this study's results.I have brain metastasis causing symptoms.I am willing to follow the study rules and provide samples for testing.I am 18 years old or older.I do not have stomach or intestine problems that could affect medicine absorption.I have heart problems that affect my daily activities.My kidneys work well enough, based on a specific calculation.
Research Study Groups:
This trial has the following groups:- Group 1: Part H: AML Maintenance Therapy- KPT-8602 single agent
- Group 2: Part G: Newly Diagnosed Intermediate/High-Risk MDS -KPT-8602 with ASTX727
- Group 3: Part A2: RRMM- KPT-8602 single agent; QoDx3/week
- Group 4: Part B: RRMM- KPT-8602 with low-dose dexamethasone; QDx5/week
- Group 5: Part D: mCRPC- KPT-8602 single agent
- Group 6: Part E: mCRPC- KPT-8602 with abiraterone and corticosteroids
- Group 7: Part F: High-risk Myelodysplastic Syndrome (MDS)- KPT-8602 single agent
- Group 8: Part F Phase 2: RR High-risk MDS- KPT-8602 single agent
- Group 9: Part A1: RRMM- KPT-8602 single agent; QoDx5/week
- Group 10: Part C: CRC- KPT-8602 single agent
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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