NCT02025985

Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies

A Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export/SINE™ Compound KPT-330 (Selinexor) in Patients With Advanced Gynaecologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in participants with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Detailed description

Two-stage Phase 2 study in 3 separate gynecological cancer cohorts, with an additional set of participants in the ovarian cohort randomized into 2 different treatment regimens. The study is divided between a Primary Treatment Phase and a Maintenance Phase with each phase supported by a separate database. Part 1 - Three parallel cohorts of participants with ovarian (Cohort A), endometrial (Cohort B), or cervical (Cohort C) carcinoma were enrolled. Part 2 - Based on the observed tolerability and efficacy profile in the ongoing ovarian cohort (Cohort A), 2 additional treatment schedules will be explored to optimize the dosing schedule in a participant population with ovarian carcinoma.

Conditions

• Ovarian Carcinoma
• Endometrial Carcinoma
• Cervical Carcinoma

Interventions

Type	Name	Description
DRUG	Selinexor	Route of administration and dosage form: Oral tablet; Doses: 35 mg/m\^2 BIW, 35 mg/m\^2 QW, 50 mg/m\^2 BIW, 50 mg/m\^2 QW, 60 mg/m\^2 BIW, 60 mg/m\^2 QW. Treatment cycles were 4 weeks each i.e., 28 day cycles.

Timeline

• Start date: 2014-04-09
• Primary completion: 2017-01-24
• Completion: 2017-03-29
• First posted: 2014-01-01
• Last updated: 2023-01-26
• Results posted: 2021-02-02

Locations

4 sites across 2 countries: Belgium, Denmark

Regulatory

• FDA-regulated drug study