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

Sponsors and Collaborators:	AstraZeneca 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 90 patients from 7 centers in Canada will be enrolled into this study.

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer

Drug Information available for: Ribose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Objective Response Rate as evaluated according to RECIST guidelines; evidence of activity in both tumour types ie CA-125 for ovarian cancer

Secondary Outcome Measures:

length of time to disease progression
Overall Survival
Safety and tolerability [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental AZD2281, PARP inhibitor	Drug: AZD2281 PARP inhibitor

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

Contacts

Contact: AstraZeneca Clinical Study Information

1-800-236-9933

information.center@astrazeneca.com

Locations

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

Sponsors and Collaborators

AstraZeneca

British Columbia Cancer Agency

Investigators

Study Chair:

Karen Gelmon, MD

British Columbia Cancer Agency

More Information

Responsible Party:	AstraZeneca ( Jim Carmichael )
Study ID Numbers:	D0810C00020
Study First Received:	May 15, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00679783
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

Study placed in the following topic categories:

Ovarian cancer
Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Ovarian epithelial cancer
Recurrence
Carcinoma
Genital Diseases, Female
Endocrinopathy
Breast Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009