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

Phase 2

Terminated

• Conditions: Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
• Interventions: Drug: Paclitaxel; Drug: ZD4054 Zibotentan; Drug: Carboplatin; Drug: Placebo

• Registration Number: NCT00929162
• Lead Sponsor: AstraZeneca

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 with carboplatin+paclitaxel.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-04-26
• Results First Submitted QC: 2012-04-26
• Results First Posted: 2012-06-06
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZD4054 + paclitaxel + carboplatin	Carboplatin	ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Placebo + paclitaxel + carboplatin	Paclitaxel	Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Placebo + paclitaxel + carboplatin	Carboplatin	Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
ZD4054 + paclitaxel + carboplatin	Paclitaxel	ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Placebo + paclitaxel + carboplatin	Placebo	Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
ZD4054 + paclitaxel + carboplatin	ZD4054 Zibotentan	ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇮🇹 Roma, Italy