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

NCT ID: NCT00929162

Last Updated: 2012-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

Keywords

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ovarian cancer chemotherapy sensitive ZD4054

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZD4054 + paclitaxel + carboplatin

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

Group Type EXPERIMENTAL

ZD4054 Zibotentan

Intervention Type DRUG

10 mg oral tablets once daily

Paclitaxel

Intervention Type DRUG

175mg/m2 IV on day 1 every 3 weeks

Carboplatin

Intervention Type DRUG

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

Placebo + paclitaxel + carboplatin

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

Group Type PLACEBO_COMPARATOR

Paclitaxel

Intervention Type DRUG

175mg/m2 IV on day 1 every 3 weeks

Carboplatin

Intervention Type DRUG

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

Placebo

Intervention Type DRUG

matching placebo for ZD4054 10 mg

Interventions

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ZD4054 Zibotentan

10 mg oral tablets once daily

Intervention Type DRUG

Paclitaxel

175mg/m2 IV on day 1 every 3 weeks

Intervention Type DRUG

Carboplatin

Carboplatin AUC of 5.0 IV on day 1 every 3 weeks

Intervention Type DRUG

Placebo

matching placebo for ZD4054 10 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ISTITUTO REGINA ELENA - CENTRO RICERCHE SPERIMENTALI

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tom Morris

Role: STUDY_DIRECTOR

AstraZeneca, Alderley Park

Ian Thomas

Role: STUDY_CHAIR

AstraZeneca, Alderley Park

Locations

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Research Site

Berlin, , Germany

Site Status

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Dresden, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Karlsruhe, , Germany

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Kassel, , Germany

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Kiel, , Germany

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Lich, , Germany

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Magdeburg, , Germany

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Marburg, , Germany

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München, , Germany

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Rostock, , Germany

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Wiesbaden, , Germany

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Milan, MI, Italy

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Perugia, PG, Italy

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Aviano, PN, Italy

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Roma, Roma, Italy

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Campobasso, , Italy

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Modena, , Italy

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Napoli, , Italy

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Countries

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Germany Italy

References

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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.

Reference Type DERIVED
PMID: 23234805 (View on PubMed)

Other Identifiers

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D4320C00036

Identifier Type: -

Identifier Source: org_study_id