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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Thank you

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

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