Status:
TERMINATED
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Conditions:
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare progression-free survival in patients with advanced ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo in combination ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00929162
Start Date
June 1 2009
End Date
June 1 2011
Last Update
August 7 2012
Active Locations (20)
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1
Research Site
Berlin, Germany
2
Research Site
Dresden, Germany
3
Research Site
Düsseldorf, Germany
4
Research Site
Essen, Germany