Efficacy and safety of pazopanib after first line chemotherapy in ovarian, fallopian tube, or primary peritoneal cancer
- Conditions
- Ovarian, fallopian tube or primary peritoneal cancerCancer - Ovarian and primary peritonealCancer - Other cancer types
- Registration Number
- ACTRN12609000591257
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 900
1. Subject has histologically confirmed, International Federation of Gynaecology and Obstetrics (FIGO) stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
2. The date of study randomization must be at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
3. Subject has had no evidence of disease progression throughout their first-line treatment and prior to study randomization
4. Subject has Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
1. Subject has either (a) bulky disease (eg, ascites that causes abdominal distention or requires paracentesis; mesenteric thickening; or tumor masses of 2 cm or more by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) identified on the baseline scan), or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
2. Subjects with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met - FIGO Stage = IB, and no lymphovascular invasion, and not poorly differentiated (i.e. not Grade 3 or papillary serous or clear cell)
3. Subject has clinically significant gastrointestinal abnormalities including, but not limited to malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess.
4. Subject has prolongation of corrected QT interval (QTc) > 480 msecs in the Screening electrocardiography (ECG).
5. Subject has a history of any one or more of the following cardiovascular conditions within the past 6 months prior to randomization: cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
6. Subject has poorly controlled hypertension [defined as systolic blood pressure (SBP) of greater than or equal to 140mmHg or diastolic blood pressure (DBP) of greater than or equal to 90mmHg].
7. Subject has a history of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization.
8. Subject has had major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures (eg, central venous access line removal) within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
9. Subject has evidence of active bleeding or bleeding diathesis.
10. Subject has had hemoptysis within 6 weeks prior to randomization.
11. Subject has known endobronchial metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS). PFS is defined as the interval between date of randomisation to earliest date of disease progression (as defined by the investigator based on Response Evaluation Criteria in Solid Tumours (RECIST) criteria) or death due to any cause.[Profression-free Survival will be analysed when there have been at least 408 progressions based on radiological evidence or deaths due to any reason; and when there have been at least 276 deaths.]
- Secondary Outcome Measures
Name Time Method Overall Survival[Overall Survival will be first analysed when there have been at least 408 radiological progressions or deaths due to any reason; and when there have been at least 276 deaths. A second analysis of Overall Survival will occur when there have been 414 deaths, and a final Overall Survival analysis when there have been 551 deaths.]