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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00628251 |
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 |
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Ovarian Neoplasms |
Drug: AZD2281 Drug: Liposomal Doxorubicin |
Phase II |
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 |
Estimated Enrollment: | 90 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
AZD2281 Oral
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Drug: AZD2281
400mg Oral twice daily
Drug: AZD2281
200mg oral twice daily
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2: Active Comparator
Liposomal Doxorubicin
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Drug: Liposomal Doxorubicin
50mg/m2 Monthly Intravenous
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Responsible Party: | AstraZeneca ( Jim Carmichael/Medical Science Director ) |
Study ID Numbers: | D0810C00012 |
Study First Received: | February 26, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00628251 History of Changes |
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 |
Advanced ovarian cancer BRCA1 protein BRCA2 protein Poly(ADP ribose) polymerases |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Doxorubicin |
Genital Diseases, Female Signs and Symptoms Anti-Bacterial Agents Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic |
Pharmacologic Actions Doxorubicin Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms |