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

Primary Purpose

Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ZD4054 Zibotentan
Paclitaxel
Carboplatin
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy focused on measuring ovarian, cancer, chemotherapy, sensitive, ZD4054

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZD4054 + paclitaxel + carboplatin

Placebo + paclitaxel + carboplatin

Arm Description

ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks

Outcomes

Primary Outcome Measures

Progression Free Survival
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.

Secondary Outcome Measures

Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Tumour Response Rate
Objective response rate defined as participants with a complete or partial response according to RECIST

Full Information

First Posted
June 25, 2009
Last Updated
August 3, 2012
Sponsor
AstraZeneca
Collaborators
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
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1. Study Identification

Unique Protocol Identification Number
NCT00929162
Brief Title
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Primary objective of the trial was not met and so there was no benefit in collecting further information
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
Keywords
ovarian, cancer, chemotherapy, sensitive, ZD4054

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZD4054 + paclitaxel + carboplatin
Arm Type
Experimental
Arm Description
ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Arm Title
Placebo + paclitaxel + carboplatin
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
Intervention Type
Drug
Intervention Name(s)
ZD4054 Zibotentan
Intervention Description
10 mg oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
175mg/m2 IV on day 1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC of 5.0 IV on day 1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo for ZD4054 10 mg
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Time Frame
Patients were followed for progression up to 2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Median time (in months) from randomisation until death using the Kaplan-Meier method.
Time Frame
Patients were followed for survival up to 2 years
Title
Tumour Response Rate
Description
Objective response rate defined as participants with a complete or partial response according to RECIST
Time Frame
While receiving paclitaxel + carboplatin study visits were aliged with its administration ie every 3 weeks, then every 6 weeks (up to 2 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Morris
Organizational Affiliation
AstraZeneca, Alderley Park
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ian Thomas
Organizational Affiliation
AstraZeneca, Alderley Park
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Dusseldorf
Country
Germany
Facility Name
Research Site
City
Essen
Country
Germany
Facility Name
Research Site
City
Karlsruhe
Country
Germany
Facility Name
Research Site
City
Kassel
Country
Germany
Facility Name
Research Site
City
Kiel
Country
Germany
Facility Name
Research Site
City
Lich
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
Marburg
Country
Germany
Facility Name
Research Site
City
Munchen
Country
Germany
Facility Name
Research Site
City
Rostock
Country
Germany
Facility Name
Research Site
City
Wiesbaden
Country
Germany
Facility Name
Research Site
City
Milano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Perugia
State/Province
PG
Country
Italy
Facility Name
Research Site
City
Aviano
State/Province
PN
Country
Italy
Facility Name
Research Site
City
Campobasso
Country
Italy
Facility Name
Research Site
City
Modena
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23234805
Citation
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.
Results Reference
derived

Learn more about this trial

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

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