This trial is active, not recruiting.

Condition ovarian cancer
Treatments masitinib (ab1010), gemcitabine
Phase phase 2
Sponsor AB Science
Start date April 2014
End date April 2018
Trial size 68 participants
Trial identifier NCT02490488, AB12008


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

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
masitinib (ab1010)
6 mg/kg/day
(Active Comparator)
1000 mg/m² administered by 30 minutes infusion once a week during 3 weeks followed by 1 week without infusion

Primary Outcomes

Overall survival (OS)
time frame: Until death of the patient, for an expected average of 2 years

Secondary Outcomes

Overall Progression Free Survival (PFS)
time frame: Until documented progression or death of the patient, for an expected average of 4 months
Overall Time To Progression (TTP)
time frame: from the randomization to the date of documented progression, for an expected average of 4 months
Best response rate
time frame: between baseline and each patient visit, for an expected average of 4 months
Quality of Life
time frame: between baseline and each patient visit, for an expected average of 4 months
Quality of Life
time frame: between baseline and each patient visit, for an expected average of 4 months
Number of participants with adverse events as a measure of safety and tolerability
time frame: Until last patient visit, for an expected average of 4 months

Eligibility Criteria

Female participants at least 18 years old.

Main inclusion criteria: 1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer either : - refractory to first line platinum treatment (defined as progressive disease while receiving or persistent disease after platinum-based therapy, according to GOG), or - candidate to third line treatment. 2. Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade ≤1 National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE v4.02), except for the laboratory values 3. Patient has at least one target lesion that can be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST) 4. ECOG Performance status ≤ 2 5. Patient with adequate organ function per laboratory tests evaluations 6. Patient with life expectancy > 3 months 7. Patient weight > 40 kg and BMI > 18 8. Female patient ≥ 18 years 9. Patient with nutritional risk index (NRI) ≥ 83.5, i.e. with no or moderate malnutrition; 10. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. 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. Patient presenting with serious cardiac disorders defined in the protocol 4. Pregnant or nursing female patient 5. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis 6. Patient treated for a cancer other than epithelial ovarian cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ WASH-OUT: 1. Patient is at least 4 weeks from any major surgery (at baseline/W0) 2. Patient treated with any investigational agent within 4 weeks prior baseline 3. Patient who had systemic chemotherapy within 4 weeks before baseline 4. Patient who had radiotherapy within 4 weeks before baseline

Additional Information

Official title A Prospective, Multicenter, Open-label, Centrally Allocated, Activecontrolled, Phase 2 Study to Evaluate the Efficacy and Safety of Masitinib in Ovarian Cancer
Principal investigator Julien Grenier, Dr
Description Masitinib Mesylate is a novel tyrosine kinase inhibitor that mainly targets c-Kit and PDGF receptors. C-KIT and platelet-derived growth factor and its receptor (PDGF-PDGFR), which promote tumour cell growth and angiogenesis are found to be over-expressed in 70% of ovarian cancers. Masitinib exhibits anti-tumoral immunotherapy activity in vivo with a potential to extend overall survival.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by AB Science.