EUCTR2013-000491-14-IT
Active, not recruiting
Phase 1
A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2/3 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. - Study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcit
AB SCIENCE0 sitesSeptember 10, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AB SCIENCE
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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, resistant, or sensitive 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
Exclusion Criteria
- •1\.Patient intolerant to gemcitabine or having received gemcitabine as a second line therapy
- •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)
- •d)Syncope without known aetiology within 3 months
Outcomes
Primary Outcomes
Not specified
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