A prospective, multicentre, 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 - OVARIA

AB Science0 sites56 target enrollmentFebruary 7, 2014

Overview

Phase: Not Applicable
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: 56
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

February 7, 2014

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

AB Science

•To be eligible the patient must fulfill the following inclusion criteria:
•1\.Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer either :
•a.refractory to first line platinum treatment (defined as progressive disease while receiving or persistent disease after platinum\-based therapy, according to GOG), or
•b.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
•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)