Study identifier:D4320C00036
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Phase 2
No
ZD4054 Zibotentan, Paclitaxel, Carboplatin, Placebo
Female
120
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
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.
Location
Location
Berlin, Germany
Location
Dresden, Germany
Location
Dusseldorf, Germany
Location
Essen, Germany
Location
Karlsruhe, Germany
Location
Kassel, Germany
Location
Kiel, Germany
Location
Lich, Germany
Arms | Assigned Interventions |
---|---|
Experimental: ZD4054 + paclitaxel + carboplatin ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | Drug: ZD4054 Zibotentan 10 mg oral tablets once daily Drug: Paclitaxel 175mg/m2 IV on day 1 every 3 weeks Drug: Carboplatin Carboplatin AUC of 5.0 IV on day 1 every 3 weeks |
Placebo Comparator: Placebo + paclitaxel + carboplatin Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks | Drug: Paclitaxel 175mg/m2 IV on day 1 every 3 weeks Drug: Carboplatin Carboplatin AUC of 5.0 IV on day 1 every 3 weeks Drug: Placebo matching placebo for ZD4054 10 mg |
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