A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.

AB Science0 sites80 target enrollmentJuly 1, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third line
Sponsor: AB Science
Enrollment: 80
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

July 1, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

AB Science

•1\.Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer) either:
•a.first line platinum\-refractory ovarian cancer (progression during first\-line platinum\-based chemotherapy)
•b.first line platinum\-resistant ovarian cancer (relapsing within 6 months after the end of first\-line chemotherapy);
•c.candidate to third line treatment (refractory or resistant to 2nd line platinum\-based therapy or patients who progressed after other type of chemotherapy in 2nd line)
•2\.Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade \= 1 Common Toxicity Criteria for Adverse Event (CTCAE v4\.03\), 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
•a.Absolute neutrophils count (ANC) \= 1\.5 x 109/L
•b.Haemoglobin \= 10 g/dl

•A patient must not be enrolled if she fulfils one of the following 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 cardiac disorders defined by at least one of the following conditions:
•a)Patient with recent cardiac history (within 6 months) of:
•\-Acute coronary syndrome
•\-Acute heart failure (class III or IV of the NYHA classification)
•\-Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
•b)Patient with cardiac failure class III or IV of the NYHA classification
•c)Patient with severe conduction disorders which are not prevented by permanent pacing (atrio\-ventricular block 2 and 3, sino\-atrial block)