Study Stopped
Primary objective of the trial was not met and so there was no benefit in collecting further information
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
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
1 other identifier
interventional
120
2 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2009
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 25, 2009
CompletedFirst Posted
Study publicly available on registry
June 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 6, 2012
CompletedAugust 7, 2012
August 1, 2012
2 years
June 25, 2009
April 26, 2012
August 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Overall Survival
Patients were followed for survival up to 2 years
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)
Study Arms (2)
ZD4054 + paclitaxel + carboplatin
EXPERIMENTALZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Placebo + paclitaxel + carboplatin
PLACEBO COMPARATORPlacebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Interventions
175mg/m2 IV on day 1 every 3 weeks
Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALIcollaborator
Study Sites (20)
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Essen, Germany
Research Site
Karlsruhe, Germany
Research Site
Kassel, Germany
Research Site
Kiel, Germany
Research Site
Lich, Germany
Research Site
Magdeburg, Germany
Research Site
Marburg, Germany
Research Site
München, Germany
Research Site
Rostock, Germany
Research Site
Wiesbaden, Germany
Research Site
Milan, MI, Italy
Research Site
Perugia, PG, Italy
Research Site
Aviano, PN, Italy
Research Site
Roma, Roma, Italy
Research Site
Campobasso, Italy
Research Site
Modena, Italy
Research Site
Napoli, Italy
Related Publications (1)
Cognetti F, Bagnato A, Colombo N, Savarese A, Scambia G, Sehouli J, Wimberger P, Sorio R, Harter P, Mari E, McIntosh S, Nathan F, Pemberton K, Baumann K. A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination with carboplatin/paclitaxel versus placebo in combination with carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to platinum-based chemotherapy (AGO-OVAR 2.14). Gynecol Oncol. 2013 Jul;130(1):31-7. doi: 10.1016/j.ygyno.2012.12.004. Epub 2012 Dec 9.
PMID: 23234805DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tom Morris
AstraZeneca, Alderley Park
- STUDY CHAIR
Ian Thomas
AstraZeneca, Alderley Park
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2009
First Posted
June 26, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
August 7, 2012
Results First Posted
June 6, 2012
Record last verified: 2012-08