Trial Information
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 (Zibotentan) Plus Carboplatin and Paclitaxel or Placebo Plus Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Inclusion Criteria:
- Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube
carcinoma - Primary serous peritoneal carcinoma
- Radiologically documented measurable disease according to RECIST criteria assessed by
Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically
documented non-measurable (but evaluable) disease.
- Advanced disease not amenable to curative surgery or radiotherapy at the time of
study entry with evidence of disease recurrence or progression at least 6 months
following treatment cessation of first-line platinum- containing therapy
Exclusion Criteria:
- Clinical evidence of central nervous system (CNS) metastases
- Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and
mucinous carcinoma of the peritoneum
- Tumour of borderline malignancy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Outcome Time Frame:
Patients were followed for progression up to 2 years
Safety Issue:
No
Principal Investigator
Tom Morris
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca, Alderley Park
Authority:
Italy: Ethics Committee
Study ID:
D4320C00036
NCT ID:
NCT00929162
Start Date:
June 2009
Completion Date:
June 2011
Related Keywords:
- Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
- ovarian
- cancer
- chemotherapy
- sensitive
- ZD4054
- Ovarian Neoplasms