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XPO1 inhibitor

KPT-8602 for Multiple Myeloma

Q: What is the efficacy of KPT-8602 in other areas?

<p>KPT-8602 was first studied in 2002 at Manitoba Blood &#x26; Marrow <a href="https://www.withpower.com/clinical-trials/transplant">Transplant</a> Program CancerCare Manitoba. So far, there have been 1107 completed trials. There are currently 579 active trials, with many of these trials taking place in Grand Rapids, <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a>.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 8 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 8 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part A1, A2, B, C, D, E, F: Clinical Benefit Rate (CBR)

Part A1, A2, B, C, D, E, F: Disease Control Rate (DCR)

Part A1, A2, B, C, D, E, F: Duration of Clinical Benefit Rate (CBR)

+9 more

Secondary outcome measures

Part A1, A2, B, C, D, E, F, H: Apparent Terminal Half Life (t1/2) of Eltanexor

Part A1, A2, B, C, D, E, F, H: Apparent Total Body Clearance Eltanexor

Part A1, A2, B, C, D, E, F, H: Apparent Volume of Distribution During Terminal Phase (VZ/f) of Eltanexor

+17 more

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

~240

Dexamethasone

2007

Completed Phase 4

~2590

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Karyopharm Therapeutics IncLead Sponsor

87 Previous Clinical Trials

7,302 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

KPT-8602 (XPO1 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02649790 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: Part H: AML Maintenance Therapy- KPT-8602 single agent, Part G: Newly Diagnosed Intermediate/High-Risk MDS -KPT-8602 with ASTX727, Part A2: RRMM- KPT-8602 single agent; QoDx3/week, Part B: RRMM- KPT-8602 with low-dose dexamethasone; QDx5/week, Part D: mCRPC- KPT-8602 single agent, Part E: mCRPC- KPT-8602 with abiraterone and corticosteroids, Part F: High-risk Myelodysplastic Syndrome (MDS)- KPT-8602 single agent, Part F Phase 2: RR High-risk MDS- KPT-8602 single agent, Part A1: RRMM- KPT-8602 single agent; QoDx5/week, Part C: CRC- KPT-8602 single agent

Myelodysplastic Syndrome Clinical Trial 2023: KPT-8602 Highlights & Side Effects. Trial Name: NCT02649790 — Phase 1 & 2

KPT-8602 (XPO1 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649790 — Phase 1 & 2

Frequently Asked Questions

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

KPT-8602 has shown to be most effective in treating what condition?

"Ophthalmologists often prescribe KPT-8602 to patients with ophthalmia, sympathetic. This medication can also be used to help manage branch retinal vein occlusion and macular edema."

Answered by AI

How many people are included in this research project?

"In order to successfully carry out this research, 277 patients that meet the eligibility requirements need to be recruited. The sponsor organisation, Karyopharm Therapeutics Inc., will manage the trial from various locations such as Cancer and Hematology Centers of Western Michigan in Grand Rapids, Michigan and (USO) Texas Oncology (Dallas) in Dallas, Texas."

Answered by AI

Are patients currently being accepted for this treatment program?

"This trial, as indicated by the clinicaltrials.gov website, is still actively looking for participants. The original posting date was 1/1/2016, with the most recent edit on 8/11/2022."

Answered by AI

In how many locations is this trial being held?

"There are a total of 25 centres recruiting for this clinical trial, including the Cancer and Hematology Centers of Western Michigan in Grand Rapids, (USO) Texas Oncology (Dallas) in Dallas, and University of New mexico in Albuquerque."

Answered by AI

What is the efficacy of KPT-8602 in other areas?

"KPT-8602 was first studied in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. So far, there have been 1107 completed trials. There are currently 579 active trials, with many of these trials taking place in Grand Rapids, Michigan."

Answered by AI

Recent research and studies

Journal of Hematology & OncologyJournal

Oral Eltanexor Treatment of Patients with Higher-risk Myelodysplastic Syndrome Refractory to Hypomethylating Agents

Lee, Sangmin, Sanjay Mohan, Jessica Knupp, Kamal Chamoun, Adrienne de Jonge, Fan Yang, Erkan Baloglu, et al.. 2022. “Oral Eltanexor Treatment of Patients with Higher-risk Myelodysplastic Syndrome Refractory to Hypomethylating Agents”. Journal of Hematology & Oncology. Springer Science and Business Media LLC. doi:10.1186/s13045-022-01319-y.

clinicaltrials.govStudy

Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications

2016. "Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02649790.

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