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A Phase II Open-Label, Non-Comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

A Phase II Open-Label, Non-Comparative, International, Multicentre Study to Assess the Efficacy and Safety of KU 0059436 Given Orally Twice Daily in Patients With Advanced BRCA1 or BRCA2 Associated Breast Cancer


Inclusion Criteria:



- Advanced breast cancer with positive BRCA1 or BRCA2 status

- Failed at least one prior chemotherapy

- In investigators opinion, no curative standard therapy exists

- Measurable disease

Exclusion Criteria:

- Brain metastases

- Less than 28 days since last treatment used to treat the disease

- Considered a poor medical risk due to a serious uncontrolled disorder

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 tumour response rate

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

James Carmichael, BSc, MBChB, MD, FRCP

Investigator Role:

Study Director

Investigator Affiliation:

KuDOS Pharmaceuticals Limited

Authority:

United States: Food and Drug Administration

Study ID:

KU36-44

NCT ID:

NCT00494234

Start Date:

June 2007

Completion Date:

February 2009

Related Keywords:

  • Breast Neoplasms
  • Advanced breast cancer
  • Poly(ADP ribose) polymerases
  • AZD2281
  • KU-0059436
  • BRCA1 protein
  • BRCA2 protein
  • Breast Neoplasms
  • Neoplasms

Name

Location
Research Site Anaheim, California  
Research Site Beverly, Massachusetts  
Research Site Albany, New York  
Research Site Allentown, Pennsylvania