platinum resistant or refractory ovarian cancer MedDRA version: 9.1 Level: LLT Classification code 10033130
Conditions
Interventions
Product Name: pazopanib
Pharmaceutical Form: Tablet
INN or Proposed INN: pazopanib
Current Sponsor code: GW786034B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Cytologic / histologic diagnosis of stage IC-IV ovarian cancer ? Disease progressed during first line chemotherapy or disease relapsed within 6 months after the last platinum treatment ? Disease evaluable by RECIST or Ca 125 GCIG criteria ? No residual peripheral neurotoxicity from previous chemotherapy treatment ? PS 0-1 ? Age ? 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) ? Previous treatment with weekly paclitaxel ? More than 2 previous chemotherapy treatments ? Serious heart disease, including heart failure, atrioventricular block of any degree, serious arrhythmia or history of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, symptomatic peripheral vascular disease, coronary artery by-pass graft surgery, class II, III or IV congestive heart failure as defined by the New York Heart Association (NYHA) ? Hemoglobin 2.5 ULN, total bilirubin > 1.5 times the UNL) ? Prothrombin time (PT) or international normalized ratio (INR) or activated partial thromboplastin time (PTT) > 1.2 times the UNL ? Pregnancy, breast feeding, or inadequate contraception ? Unable to discontinue prohibited medications (see protocol section 6.7) ? Clinically significant gastrointestinal abnormalities which might interfere with oral dosing, including but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment, signs or symptoms of GI obstruction ? Any unstable or serious concurrent condition ? Prolongation of corrected QT interval (QTc) >480 ms ? History of cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months ? Macroscopic hematuria ? Major surgery or trauma within 30 days ? Hypertension uncontrolled with adequate therapy (systolic blood pressure (BP) of ? 140mmHg, or diastolic BP of ? 90mmHg) ? Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity ? Present or suspected haemorrhagic syndromes ? Patients` inability to access the centre due to area of residence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of a combination of pazopanib and weekly paclitaxel compared to weekly paclitaxel in terms of progression-free survival (PFS).;Secondary Objective: To assess: ?Toxicity ?Response rate ?Overall survival (OAS);Primary end point(s): PROGRESSION FREE SURVIVAL | — |
Countries
Italy
Outcome results
None listed