Phase 2 N=91 Treatment

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

Ovarian Carcinoma · Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00679783 ↗

Enrolled (actual)

Serious AEs

15.6%

Results posted

Aug 2011

Primary outcome: Primary: Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines — 75; 30.77; 0; 25.58 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AZD2281 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines	75; 30.77; 0; 25.58; 0; 0	—
SECONDARY Disease Control Rate (DCR)	75; 53.85; 0; 47.73; 60; 20	—
SECONDARY Duration of Response	277; 113; 384	—
SECONDARY Best Percentage Change From Baseline in Tumour Size	-44.5; -21.6; 33.6; -14.1; -35.3; -36.4	—
SECONDARY CA-125 Levels (Ovarian Cancer Patients Only)	75; 33.33; 0; 28.57	—
SECONDARY Progression Free Survival (PFS)	346.5; 219; 79.5; 192; 165; 106	—

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

Eligibility 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 .

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00679783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.