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

Sponsor:	AstraZeneca
Information provided by (Responsible Party):	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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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 ]

Enrollment:	326
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
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 penultimate chemo regimen.
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

Show 76 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Robertson, BSc, MBCHB, MD	AstraZeneca
Principal Investigator:	Prof Jonathan A Lederman	University College, London

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. Epub 2012 Mar 27.

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

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00753545 History of Changes
Other Study ID Numbers:	D0810C00019
Study First Received:	September 12, 2008
Last Updated:	October 11, 2011
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)

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases

Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2012