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Also known as Eltanexor
KPT-8602 · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Part A1: RRMM- KPT-8602 single agent; QoDx5/week | EXPERIMENTAL | Participants received KPT-8602 once daily for 5 days per week (QDx5/week) at escalated doses (completed). |
| Part A2: RRMM- KPT-8602 single agent; QoDx3/week | EXPERIMENTAL | 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). |
| Part B: RRMM- KPT-8602 with low-dose dexamethasone; QDx5/week | EXPERIMENTAL | 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). |
| Part C: CRC- KPT-8602 single agent | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed). |
| Part D: mCRPC- KPT-8602 single agent | EXPERIMENTAL | Participants were treated with KPT-8602 at a dose and schedule that has been cleared in Part A (completed). |
| Part E: mCRPC- KPT-8602 with abiraterone and corticosteroids | EXPERIMENTAL | 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). |
| Part F: High-risk Myelodysplastic Syndrome (MDS)- KPT-8602 single agent | EXPERIMENTAL | 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). |
| Part F Phase 2: RR High-risk MDS- KPT-8602 single agent | EXPERIMENTAL | 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. |
| Part G: Newly Diagnosed Intermediate/High-Risk MDS -KPT-8602 with ASTX727 | EXPERIMENTAL | 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. |
| Part H: AML Maintenance Therapy- KPT-8602 single agent | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| KPT-8602 | DRUG | Participants will receive KPT-8602 oral tablets. |
| ASTX727 | DRUG | ASTX727 is a combination drug of 35 mg decitabine and 100 mg cedazuridine. |
| Dexamethasone | DRUG | Participants will receive dexamethasone oral tablets. |
INCLUSION CRITERIA 1. Written informed consent signed prior to any screening procedures and in accordance with federal, local, and institutional guidelines. 2. Age ≥ 18 years. 3. Adequate hepatic function: 1. total bilirubin ≤ 2 times the upper limit of normal (ULN) (except participants with Gi...
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KPT-8602 is an investigational small molecule developed by Karyopharm Therapeutics Inc. (ticker KPTI) for relapsed or refractory multiple myeloma and other advanced cancers. It is an oral agent that has been studied in a Phase 1 clinical trial. It is not an approved therapy and remains in clinical development.
KPT-8602 has been studied in relapsed or refractory multiple myeloma (RRMM). The Phase 1 trial also enrolled participants with metastatic colorectal cancer, metastatic castration-resistant prostate cancer, higher-risk myelodysplastic syndrome, acute myeloid leukemia, and newly diagnosed intermediate or high-risk MDS. It is investigational and not approved for any indication.
KPT-8602 targets XPO1, also known as exportin 1, a protein that mediates nuclear export of cargo proteins. By binding XPO1, the drug is designed to interfere with that export process in cancer cells. XPO1 is the same molecular target addressed by other Karyopharm compounds.
KPT-8602 is being developed by Karyopharm Therapeutics Inc., which trades on the Nasdaq under the ticker KPTI. Karyopharm is the sponsor of the clinical program evaluating the compound in hematologic and solid tumor indications.
KPT-8602 is in Phase 1 development. Its single registered trial, NCT02649790, was a Phase 1 study of safety, tolerability, and efficacy in participants with relapsed or refractory cancer indications. That trial is completed, and KPT-8602 is not an FDA-approved product.
KPT-8602 has been evaluated in one registered clinical trial, NCT02649790, titled a study of the safety, tolerability, and efficacy of KPT-8602 in participants with relapsed or refractory cancer indications. It was a Phase 1, controlled study that enrolled 277 participants across the United States, Canada, China, France, and Spain, and it is now completed.