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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Ovarian Carcinoma, Breast Cancer

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Trial Information

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


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 .

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Karen Gelmon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

D0810C00020

NCT ID:

NCT00679783

Start Date:

July 2008

Completion Date:

December 2012

Related Keywords:

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

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