EUCTR2013-000491-14-GB
Active, not recruiting
Not Applicable
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. - Phase 2 comparing masitinib with gemcitabine in ovarian cancer v1
AB Science0 sites80 target enrollmentAugust 18, 2014
ConditionsAdvanced / metastatic epithelial ovarian cancer patients in secondline being refractory to first line platinum treatment or in third lineMedDRA version: 18.0Level: PTClassification code 10033158Term: Ovarian epithelial cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsGemcitabine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced / metastatic epithelial ovarian cancer patients in secondline being refractory to first line platinum treatment or in third line
- Sponsor
- AB Science
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 10 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 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
Exclusion Criteria
- •EXCLUSION CRITERIA
- •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
Outcomes
Primary Outcomes
Not specified
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