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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679783
• Other study ID #: D0810C00020
• Status: Completed
• Phase: Phase 2
• Start date: July 8, 2008
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 20, 2022
• Est. primary completion date: March 26, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ovarian Epithelial
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Drug:
• AZD2281
PARP inhibitor Olaparib tablets, oral

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines	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.	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.
Secondary	Disease Control Rate (DCR)	Percentage of participants with confirmed best Response Evaluation Criteria In Solid Tumours (RECIST) response of complete response (CR), partial response (PR) orStable Disease (SD)	16 Weeks
Secondary	Duration of Response	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.	RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.
Secondary	Best Percentage Change From Baseline in Tumour Size	The best percentage change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).	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.
Secondary	CA-125 Levels (Ovarian Cancer Patients Only)	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.	24 weeks
Secondary	Progression Free Survival (PFS)	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.	RECIST tumour assessments carried out every 8 weeks from randomization (+/- 2 weeks) until data cut-off on 26 March 2010.

External Links

•   D0810C00020_CSR_Synopsis