NCT02269293

Selective Inhibitor of Nuclear Export, Selinexor (KPT-330) in Combination With Paclitaxel and Carboplatin in Patients With Advanced Ovarian or Endometrial Cancers

Completed Phase 1 Last updated 23 April 2021

What this trial tests

Phase 1 trial testing Paclitaxel in Ovarian Cancer in 23 participants. Completed in 20 April 2021.

Timeline

13 October 2014

Primary endpoint
20 April 2021

20 April 2021

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	13 October 2014
Primary completion	20 April 2021
Estimated completion	20 April 2021
Sites	3 locations across United States

Drugs / interventions tested

• Paclitaxel — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Selinexor — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer or Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to test the safety of the investigational drug, selinexor (KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will be given at two different dosing schedules and selinexor will be given at two different dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer. The investigators want to find out what effects, good and/or bad, selinexor has on the patient and the cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Regulated cell death (RCD) in cancer: key pathways and targeted therapies.
   Peng F, Liao M, Qin R, Zhu S, et al · · 2022 · cited 586× · PMID 35963853 · DOI 10.1038/s41392-022-01110-y
2. Mitochondria-associated programmed cell death as a therapeutic target for age-related disease.
   Nguyen TT, Wei S, Nguyen TH, Jo Y, et al · · 2023 · cited 221× · PMID 37612409 · DOI 10.1038/s12276-023-01046-5
3. XPO1-dependent nuclear export as a target for cancer therapy.
   Azizian NG, Li Y. · · 2020 · cited 183× · PMID 32487143 · DOI 10.1186/s13045-020-00903-4
4. The past, present, and future of CRM1/XPO1 inhibitors.
   Wang AY, Liu H. · · 2019 · cited 85× · PMID 30976603 · DOI 10.21037/sci.2019.02.03
5. New therapies for advanced, recurrent, and metastatic endometrial cancers.
   Makker V, Green AK, Wenham RM, Mutch D, et al · · 2017 · cited 74× · PMID 29214032 · DOI 10.1186/s40661-017-0056-7
6. The nuclear export protein exportin-1 in solid malignant tumours: From biology to clinical trials.
   Lai C, Xu L, Dai S. · · 2024 · cited 16× · PMID 38783482 · DOI 10.1002/ctm2.1684
7. A phase I open-label study of selinexor with paclitaxel and carboplatin in patients with advanced ovarian or endometrial cancers.
   Rubinstein MM, Grisham RN, Cadoo K, Kyi C, et al · · 2021 · cited 11× · PMID 33139041 · DOI 10.1016/j.ygyno.2020.10.019
8. Inhibition of exportin-1 function results in rapid cell cycle-associated DNA damage in cancer cells.
   Burke RT, Marcus JM, Orth JD. · · 2017 · cited 7× · PMID 28467801 · DOI 10.18632/oncotarget.17063