AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

NCT ID: NCT00610714

Last Updated: 2012-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-01-31

Brief Summary

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The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

Detailed Description

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Conditions

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Ovarian Neoplasms Ovarian Cancer

Keywords

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Cancer Tumour Ovarian Neoplasms Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active Comparator

carboplatin plus paclitaxel

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

intravenous injection

Paclitaxel

Intervention Type DRUG

intravenous infusion

2

AZD0530 in combination with carboplatin plus paclitaxel

Group Type EXPERIMENTAL

AZD0530

Intervention Type DRUG

oral once daily dose

Carboplatin

Intervention Type DRUG

intravenous injection

Paclitaxel

Intervention Type DRUG

intravenous infusion

Interventions

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AZD0530

oral once daily dose

Intervention Type DRUG

Carboplatin

intravenous injection

Intervention Type DRUG

Paclitaxel

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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CBDCA Paraplatin® Taxol®

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis of advanced ovarian cancer
* Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
* Estimated life expectancy of more than 12 weeks

Exclusion Criteria

* Central Nervous System (CNS) metastases
* Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low haemoglobin
* Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Poole, Prof

Role: PRINCIPAL_INVESTIGATOR

Dept. of Oncology, University Hospital, Clifford Bridge Road, Walsgrave, Coventry

Mireille Cantarini, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Aalborg, , Denmark

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Herning, , Denmark

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Næstved, , Denmark

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Paris, Cedex 04, France

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Avignon, , France

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Bordeaux, , France

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Caen, , France

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Lyon, , France

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Montpellier, , France

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Nantes, , France

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Pierre-Bénite, , France

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Reims, , France

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Vandœuvre-lès-Nancy, , France

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Amsterdam, , Netherlands

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Leiden, , Netherlands

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Nijmegen, , Netherlands

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The Hague, , Netherlands

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Bergen, , Norway

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Oslo, , Norway

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Lima, Lima Province, Peru

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Coimbra, , Portugal

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Funchal, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Baia Mare, Maramureş, Romania

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Alba Iulia, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Kazan', , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Córdoba, Andalusia, Spain

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Barcelona, Catalonia, Spain

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Hospitalet Dellobregat(barcelo, Catalonia, Spain

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Madrid, Madrid, Spain

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Valencia, Valencia, Spain

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Coventry, , United Kingdom

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Countries

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Bulgaria Canada Denmark France Netherlands Norway Peru Portugal Romania Russia Spain United Kingdom

References

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Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.

Reference Type DERIVED
PMID: 19238149 (View on PubMed)

Other Identifiers

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AZD0530 Study 15

Identifier Type: -

Identifier Source: secondary_id

D8180C00015

Identifier Type: -

Identifier Source: org_study_id