ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
This study has been terminated.
(Primary objective of the trial was not met and so there was no benefit in collecting further information)
Sponsor:
AstraZeneca
Collaborator:
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00929162
First received: June 25, 2009
Last updated: August 3, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy |
Drug: ZD4054 Zibotentan Drug: Paclitaxel Drug: Carboplatin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: Patients were followed for progression up to 2 years ] [ Designated as safety issue: No ]Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Patients were followed for survival up to 2 years ] [ Designated as safety issue: No ]Median time (in months) from randomisation until death using the Kaplan-Meier method.
- Tumour Response Rate [ 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) ] [ Designated as safety issue: No ]Objective response rate defined as participants with a complete or partial response according to RECIST
| Enrollment: | 120 |
| Study Start Date: | June 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929162
Locations
| Germany | |
| Research Site | |
| Berlin, Germany | |
| Research Site | |
| Dresden, Germany | |
| Research Site | |
| Dusseldorf, Germany | |
| Research Site | |
| Essen, Germany | |
| Research Site | |
| Karlsruhe, Germany | |
| Research Site | |
| Kassel, Germany | |
| Research Site | |
| Kiel, Germany | |
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| Lich, Germany | |
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| Magdeburg, Germany | |
| Research Site | |
| Marburg, Germany | |
| Research Site | |
| Munchen, Germany | |
| Research Site | |
| Rostock, Germany | |
| Research Site | |
| Wiesbaden, Germany | |
| Italy | |
| Research Site | |
| Milano, MI, Italy | |
| Research Site | |
| Perugia, PG, Italy | |
| Research Site | |
| Aviano, PN, Italy | |
| Research Site | |
| Campobasso, Italy | |
| Research Site | |
| Modena, Italy | |
| Research Site | |
| Napoli, Italy | |
| Research Site | |
| Roma, Italy | |
Sponsors and Collaborators
AstraZeneca
ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI
Investigators
| Study Director: | Tom Morris | AstraZeneca, Alderley Park |
| Study Chair: | Ian Thomas | AstraZeneca, Alderley Park |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00929162 History of Changes |
| Other Study ID Numbers: | D4320C00036 |
| Study First Received: | June 25, 2009 |
| Results First Received: | April 26, 2012 |
| Last Updated: | August 3, 2012 |
| Health Authority: | Italy: Ethics Committee Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AstraZeneca:
|
ovarian cancer chemotherapy sensitive ZD4054 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013