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A Prospective, Multicenter, Open-label, Centrally Allocated, Activecontrolled, Phase 2 Study to Evaluate the Efficacy and Safety of Masitinib in Ovarian Cancer

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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • 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.
  • 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
  • Patient has at least one target lesion that can be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
  • ECOG Performance status ≤ 2
  • Patient with adequate organ function per laboratory tests evaluations
  • Patient with life expectancy > 3 months
  • Patient weight > 40 kg and BMI > 18
  • Female patient ≥ 18 years
  • Patient with nutritional risk index (NRI) ≥ 83.5, i.e. with no or moderate malnutrition;
  • 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

  • Patient intolerant to gemcitabine
  • Patient who has not recovered from any significant treatment toxicities prior to baseline (≥Grade 2)
  • Patient presenting with serious cardiac disorders defined in the protocol
  • Pregnant or nursing female patient
  • Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
  • 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:
  • Patient is at least 4 weeks from any major surgery (at baseline/W0)
  • Patient treated with any investigational agent within 4 weeks prior baseline
  • Patient who had systemic chemotherapy within 4 weeks before baseline
  • Patient who had radiotherapy within 4 weeks before baseline

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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