Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer - Full Text View

Sponsor:	AstraZeneca
Collaborator:	British Columbia Cancer Agency
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00679783

Purpose

This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study.

Condition	Intervention	Phase
Ovarian Carcinoma Breast Cancer	Drug: AZD2281	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II, Open Label, Non-Randomized Study of AZD2281 in the Treatment of Patients With Known BRCA or Recurrent High Grade Serous/ Undifferentiated Tubo-Ovarian Carcinoma and in Known BRCA or Triple Negative Breast Cancer to Determine Response Rate and Correlative Markers of Response

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer Help Me Understand Genetics

MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer

Drug Information available for: AZD 2281

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines [ Time Frame: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ] [ Designated as safety issue: No ]
Percentage of participants with confirmed best RECIST response of complete response (CR) or partial response (PR). Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

Secondary Outcome Measures:

Disease Control Rate (DCR) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)
Duration of Response [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ] [ Designated as safety issue: No ]
Duration of response is measured from the time the measurement criteria for CR or PR are met (whichever is first recorded) until the patient progresses (per RECIST criteria). If patient did not progress, they are censored at their last objective tumour assessment date.
Best Percentage Change From Baseline in Tumour Size [ Time Frame: Each patient with measurable disease at baseline was assessed for best percentage change in tumour size from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization. ] [ Designated as safety issue: No ]
The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
CA-125 Levels (Ovarian Cancer Patients Only) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
A response according to CA-125 has occurred if there is at least a 50% reduction in CA-125 levels from a pre-treatment sample.
Progression Free Survival (PFS) [ Time Frame: RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010. ] [ Designated as safety issue: No ]
PFS is defined as the time from first dose to the earlier date of radiologic progression (as per Response Evaluation Criteria In Solid Tumours (RECIST) criteria or death by any cause in the absence of objective progression.

Enrollment:	91
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2011
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD2281, PARP inhibitor	Drug: AZD2281 PARP inhibitor Other Name: Olaparib

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum
Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast
Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma.
Performance status of no more than 2.

Exclusion Criteria:

Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry
Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679783

Locations

Canada, Alberta
Research Site
Edmonton, Alberta, Canada
Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada

Sponsors and Collaborators

AstraZeneca

British Columbia Cancer Agency

Investigators

Study Chair:	Karen Gelmon, MD	British Columbia Cancer Agency
Study Director:	Jane Robertson, BSc, MBCHB, MD	AstraZeneca

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):

Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, Huntsman D, Clemons M, Gilks B, Yerushalmi R, Macpherson E, Carmichael J, Oza A. Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study. Lancet Oncol. 2011 Sep;12(9):852-61. Epub 2011 Aug 19.

Responsible Party:	Jane Robertson, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00679783 History of Changes
Other Study ID Numbers:	D0810C00020
Study First Received:	May 15, 2008
Results First Received:	July 19, 2011
Last Updated:	July 19, 2011
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Breast cancer
Ovarian cancer
BRCA
Triple negative

Poly(ADP ribose) polymerases
Known BRCA or Recurrent High Grade Serious/ Undifferentiated Tubo- Ovarian Carcinoma
Known BRCA or Triple Negative Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type

Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on February 09, 2012