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

NCT02025985 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2023-01-26

Study results available
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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.

Conditions

  • Ovarian Carcinoma
  • Endometrial Carcinoma
  • Cervical Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-09
Primary Completion
2017-01-24
Completion
2017-03-29
FDA Drug
Yes

Countries

  • Belgium
  • Denmark

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02025985 on ClinicalTrials.gov