Overview

This trial is active, not recruiting.

Conditions ovarian carcinoma, breast cancer
Treatment azd2281
Phase phase 2
Target PARP
Sponsor AstraZeneca
Collaborator British Columbia Cancer Agency
Start date July 2008
End date March 2010
Trial size 112 participants
Trial identifier NCT00679783, D0810C00020

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AZD2281, PARP inhibitor
azd2281 Olaparib
PARP inhibitor

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
Disease Control Rate (DCR)
time frame: 16 Weeks
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.
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.
CA-125 Levels (Ovarian Cancer Patients Only)
time frame: 24 weeks
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.

Eligibility Criteria

Male or female participants at least 18 years old.

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 .

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by AstraZeneca.