Assessment of Efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00753545

Purpose

The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy.

Condition	Intervention	Phase
Ovarian Cancer	Drug: AZD2281 Drug: matching placebo	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Ribose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary objective of this study is to determine the efficacy (assessed by progression free survival [PFS]) of AZD2281 compared to placebo in this patient population [ Time Frame: Radiological tumour assessments will occur every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objectives of this study are to determine the efficacy of AZD2281 compared to placebo by assessment of overall survival (OS), best overall response, duration of response, Cancer antigen (CA)-125 response (Gynecologic CancerInterGroup [GCIG] [ Time Frame: CA-125 measurements will be performed every 28 daysradiological tumour assessments will be performed every 12 weeks for 1st 60 weeks and then every 24 weeks ] [ Designated as safety issue: No ]
Adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, haematology and urinalysis. [ Time Frame: Safety assessments will generally be performed every 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZD2281	Drug: AZD2281 Oral 400mg bid
2: Placebo Comparator matching placebo	Drug: matching placebo matching placebo bid

Eligibility

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

Criteria

Inclusion Criteria:

Female patients with histologically diagnosed serous ovarian cancer or recurrent serous ovarian cancer.
Patients must have completed at least 2 previous courses of platinum containing therapy; the patient must have been platinum sensitive to the previous 2 chemo regimens.
For the last chemotherapy course prior to enrolment on the study, patients must have demonstrated an objective stable maintained response (partial or complete response) and this response needs to be maintained until completion of chemotherapy.
Patients must be treated on the study within 8 wks of completion of their final dose of the platinum containing regimen.

Exclusion Criteria:

Previous treatment with PARP inhibitors including AZD2281
Patients with low grade ovarian carcinoma.
Patients who have had drainage of their ascites during the final 2 cycles of their last chemotherapy regimen prior to enrolment on the study
Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753545

Contacts

Contact: AstraZeneca Clinical Study, Information

800-236-9933

information.center@astrazeneca.com

Show 50 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	James Carmichael, BSc, MBCHB, MD, FRCP	AstraZeneca
Principal Investigator:	Prof Jonathan A Lederman	University College, London

More Information

Responsible Party:	AstraZeneca ( James Carmichael, MD, Medical Science Director )
Study ID Numbers:	D0810C00019
Study First Received:	September 12, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00753545
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Israel: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Serous,
Ovarian cancer,
PARP,
BRCA1,

BRCA2,
Poly(ADP ribose) polymerases,
Platinum sensitive,
Homologous Recombination Deficiency (HRD)

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009