EUCTR2013-000491-14-FR
Active, not recruiting
Not Applicable
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 sites56 target enrollmentFebruary 7, 2014
ConditionsAdvanced/metastatic epithelial ovarian cancer in second line being refractory to first line platinum treatment or in third lineMedDRA version: 16.1Level: 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]
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
- 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.refractory to first line platinum treatment (i.e. progression or stable disease within a 6 months first line platinum treatment period), 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
- •c.Platelets (PLT) \= 75 x 109/L
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)
- •d)Syncope without known aetiology within 3 months
Outcomes
Primary Outcomes
Not specified
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