Overview

This trial is active, not recruiting.

Conditions ovarian carcinoma, endometrial carcinoma, cervical carcinoma, breast cancer
Treatment selinexor
Phase phase 2
Sponsor Karyopharm Therapeutics, Inc
Start date January 2014
End date December 2016
Trial size 106 participants
Trial identifier NCT02025985, KCP-330-005

Summary

The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients 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 RECIST 1.1 criteria).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
3 Cohorts of patients with ovarian, endometrial, or cervical carcinoma will receive oral Selinexor 50 mg/m2 twice weekly.
selinexor KPT-330
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
(Experimental)
Ongoing ovarian carcinoma cohort will receive oral Selinexor 35 mg/m2 twice weekly.
selinexor KPT-330
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
(Experimental)
Ongoing ovarian carcinoma cohort will receive oral Selinexor 50 mg/m2 once weekly.
selinexor KPT-330
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.
(Experimental)
Breast cancer cohorts will receive oral Selinexor 60 mg twice weekly.
selinexor KPT-330
35 mg/m2 twice weekly, 50 mg/m2 twice weekly, 50 mg/m2 once weekly, or 60 mg/m2 twice weekly. Cycles are 4 weeks.

Primary Outcomes

Measure
Determine the efficacy of KPT-330 (selinexor) by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD), assessed according to RECIST 1.1 criteria).
time frame: 12 weeks

Secondary Outcomes

Measure
Evaluate safety and tolerability.
time frame: During treatment and 30 days after treatment.
Determine efficacy of selinexor in advanced or metastatic gynaecological cancers or breast cancer.
time frame: Up to 24 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Ovarian, fallopian tube or peritoneal carcinoma: both platinum refractory and platinum resistant patients, who have received ≥ 1 lines of chemotherapy for relapsed disease (i.e., ≥2 lines of chemotherapy in total). - Endometrial carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage IV, IIIc) disease. - Cervical carcinoma: patients must have received ≥ 1 lines of chemotherapy for relapsed or advanced (stage IVb) disease. - Breast cancer: adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection or any other curative treatment. - Breast cancer: Patients must have received ≥ 1 line of endocrine treatment or chemotherapy for metastatic disease as applicable for the respective breast cancer subtype. - Breast cancer: Patient must have either triple negative cancer or be hormone receptor positive (i.e., ER+ and/or PR+) and HER2 negative. - Must have either measurable disease (RECIST 1.1) or evaluable disease outside irradiated field on CT/MRI. A rise in CA-125 or other tumor marker alone is not sufficient. - ECOG performance status of 0-1. - Life expectancy of at least 12 weeks. - Able to swallow and retain oral medication. Exclusion Criteria: - Evidence of complete or partial bowel obstruction. - Gynecological cancer: All non-epithelial cancers of the ovary, fallopian tube, peritoneum, endometrium or cervix as well as neuro-endocrine tumors are excluded. - Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) ≤ 3 weeks prior to C1D1. - Chemotherapy, immunotherapy or systemic anticancer therapy ≤ 3 weeks prior to C1D1.

Additional Information

Official title 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 and Metastatic Breast Cancer
Principal investigator Ignace Vergote, MD
Description There are two different dosing schedules for ovarian cancer patients. Two additional treatment schedules will be explored in the ovarian cohort to optimize the dosing schedule in a patient population with ovarian carcinoma. Two parallel cohorts of patients with breast carcinoma will also be enrolled.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Karyopharm Therapeutics, Inc.