Dose-Finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628251

Purpose

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Condition	Intervention	Phase
Ovarian Neoplasms	Drug: AZD2281 Drug: Liposomal Doxorubicin	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ribose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-Based Chemotherapy

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Efficacy comparison of 400 mg bd and 200 mg bd AZD2281 v 50mg/m2 doxil every 4 weeks in BRCA1 or 2 associated advanced ovarian cancer patients by PFS (primary variable), ORR, duration of response and CA-125 levels [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of safety and tolerability [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD2281 Oral	Drug: AZD2281 400mg Oral twice daily Drug: AZD2281 200mg oral twice daily
2: Active Comparator Liposomal Doxorubicin	Drug: Liposomal Doxorubicin 50mg/m2 Monthly Intravenous

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced ovarian cancer with positive BRCA1 or BRCA2 status
Progressive or recurrent disease after platinum-based chemotherapy
Measurable disease by RECIST

Exclusion Criteria:

Previous anthracycline treatment
Brain metastases
Less than 28 days since last treatment used to treat the disease
Considered a poor medical risk due to a serious uncontrolled disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628251

Contacts

Contact: AstraZeneca Clinical Study Information, outside US	866-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com

Show 27 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	James Carmichael, BSc, MBCHB, MD, FRCP	KuDOS Pharmaceuticals, Ltd
Principal Investigator:	Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi	Royal Marsden NHS Foundation Trust

More Information

US and Canada only This link exits the ClinicalTrials.gov site

Responsible Party:	AstraZeneca ( Jim Carmichael/Medical Science Director )
Study ID Numbers:	D0810C00012
Study First Received:	February 26, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00628251
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Australia: Department of Health and Ageing Therapeutic Goods Administration; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; Spain: Ministry of Health; Israel: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:

Advanced ovarian cancer
BRCA1 protein
BRCA2 protein
Poly(ADP ribose) polymerases

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Signs and Symptoms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Doxorubicin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Antibiotics, Antineoplastic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009