Overview

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