ZD4054 (Zibotentan) or Placebo plus chemotherapy in Patients with Advanced Ovarian Cancer
Study identifier:D4320C00036
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
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
Medical condition
Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Phase
Phase 2
Healthy volunteers
No
Study drug
ZD4054 Zibotentan, Paclitaxel, Carboplatin, Placebo
Sex
Female
Actual Enrollment
120
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Jun 2011
Study Completion Date: 01 Jun 2011
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Tom Morris
AstraZeneca, Alderley Park
