Masitinib in Combination With Gemcitabine in Advanced/Metastatic Epithelial Ovarian Cancer Patients

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective is to evaluate the efficacy and safety of masitinib in combination with gemcitabine in refractory ovarian cancer patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Science
• Treatments: Gemcitabine

Criteria

Main inclusion criteria:

1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer), which is either:

• First line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)

• First line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);

• Candidate to third line of treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).

2. Patient with adequate organ function per laboratory tests evaluations

Main exclusion criteria:

1. Patient intolerant to gemcitabine

2. Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)

3. Pregnant or nursing female patient