ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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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 with carboplatin+paclitaxel.

Official Title
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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

Conditions
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Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Intervention / Treatment
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* Drug: ZD4054 Zibotentan
* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZD4054 + paclitaxel + carboplatin<br>ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | Drug: ZD4054 Zibotentan<br>* 10 mg oral tablets once daily<br>Drug: Paclitaxel<br>* 175mg/m2 IV on day 1 every 3 weeks<br>Drug: Carboplatin<br>* Carboplatin AUC of 5.0 IV on day 1 every 3 weeks<br>|
| Placebo Comparator: Placebo + paclitaxel + carboplatin<br>Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | Drug: Paclitaxel<br>* 175mg/m2 IV on day 1 every 3 weeks<br>Drug: Carboplatin<br>* Carboplatin AUC of 5.0 IV on day 1 every 3 weeks<br>Drug: Placebo<br>* matching placebo for ZD4054 10 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. | Patients were followed for progression up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Median time (in months) from randomisation until death using the Kaplan-Meier method. | Patients were followed for survival up to 2 years | 
| Tumour Response Rate | Objective response rate defined as participants with a complete or partial response according to RECIST | While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian, cancer, chemotherapy, sensitive, ZD4054