Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02649790 | Study of the Safety, Tolerability and Efficacy of KPT-8602 in Participants With Relapsed/Refractory Cancer Indications | PHASE1 | COMPLETED | 277 | — | — | Jan 1, 2016 | Dec 23, 2024 | Mar 19, 2025 | 46 | United States, Canada +3 |
| 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...