drugset / Trial / NCT02419495
Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies
Phase 1
Terminated
221 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.
Timeline
- Start
- 2015-06-26
- Primary completion
- 2024-09-16
- Completion
- 2024-09-16
Publications
- Alhalabi O, Gouda MA, Milton DR, Momin HA, Yilmaz B, Stephen B, Ejezie CL, Moyers JT, Gurses SA, How J, Fu S, Rodon J, Hong DS, Piha-Paul SA, Subbiah V, Elena Dumbrava E, Karp DD, Janku F, Meric-Bernstam F, Tannir NM, Naing A. A Phase IB Trial of Selinexor in Combination With Immune Checkpoint Blockade in Patients With Advanced Renal Cell Carcinoma. Cancer Med. 2025 Feb;14(4):e70280. doi: 10.1002/cam4.70280.
- Gouda MA, Zarifa A, Yang Y, Stephen B, Gurses SA, Sprenger A, Tian Y, Derbala MH, Oliva IG, Meric-Bernstam F, Patel SP. Selinexor (KPT-330) in Combination with Immune Checkpoint Inhibition in Uveal Melanoma: A Phase 1B Trial. J Immunother Precis Oncol. 2025 Jan 15;8(1):82-88. doi: 10.36401/JIPO-24-10. eCollection 2025 Feb.
- Altan M, Tu J, Milton DR, Yilmaz B, Tian Y, Fossella FV, Mott FE, Blumenschein GR, Stephen B, Karp DD, Meric-Bernstam F, Heymach JV, Naing A. Safety, tolerability, and clinical activity of selinexor in combination with pembrolizumab in treatment of metastatic non-small cell lung cancer. Cancer. 2023 Sep 1;129(17):2685-2693. doi: 10.1002/cncr.34820. Epub 2023 May 2.
- Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Fu S, Subbiah V, Hong DS, Yap TA, Shah J, Milton DR, McQuinn L, Gong J, Tran Y, Carter BW, Colen R, Meric-Bernstam F, Naing A. Selinexor in combination with standard chemotherapy in patients with advanced or metastatic solid tumors. Exp Hematol Oncol. 2021 Dec 29;10(1):59. doi: 10.1186/s40164-021-00251-0.
- Thein KZ, Karp DD, Tsimberidou A, Gong J, Sulovic S, Shah J, Milton DR, Hong DS, Janku F, McQuinn L, Stephen BA, Colen R, Carter BW, Yap TA, Piha-Paul SA, Fu S, Meric-Bernstam F, Naing A. Selinexor in combination with carboplatin and paclitaxel in patients with advanced solid tumors: Results of a single-center, multi-arm phase Ib study. Invest New Drugs. 2022 Apr;40(2):290-299. doi: 10.1007/s10637-021-01188-1. Epub 2021 Sep 25.
- Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs. 2021 Oct;39(5):1357-1365. doi: 10.1007/s10637-021-01119-0. Epub 2021 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |
| Subject | Selinexor | Other / unclassified | 80 mg | Oral |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Eribulin | Small molecule | — | Intravenous |
| Background | Ipilimumab | Monoclonal antibody | — | Oral |
| Background | Irinotecan | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Olaparib | Small molecule | — | Oral |
| Background | Oxaliplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |
| Background | Topotecan | Small molecule | — | Intravenous |
| Background | fluorouracil | Small molecule | — | Intravenous |