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A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Neoplasms

Thank you

Trial Information

A Phase II, Open-Label, Randomised, Comparative, International Multicentre Study to Assess the Safety and Efficacy of Different Doses of AZD2281 Given Orally Twice Daily Versus Intravenous Liposomal Doxorubicin Given Monthly in Patients With Advanced BRCA1- or BRCA2-Associated Ovarian Cancer Who Have Failed Previous Platinum-based Chemotherapy


Inclusion Criteria:



- Advanced ovarian cancer with positive BRCA1 or BRCA2 status

- Progressive or recurrent disease after platinum-based chemotherapy

- Measurable disease by RECIST

Exclusion Criteria:

- Previous anthracycline treatment

- 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: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy comparison of 400 mg bd and 200 mg bd AZD2281 v 50mg/m2 doxil every 4 weeks in BRCA1 or 2 associated advanced ovarian cancer patients by PFS (primary variable), ORR, duration of response and CA-125 levels

Outcome Time Frame:

every 4 weeks

Safety Issue:

No

Principal Investigator

Jane Robertson, BSc, MBCHB, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D0810C00012

NCT ID:

NCT00628251

Start Date:

July 2008

Completion Date:

December 2013

Related Keywords:

  • Ovarian Neoplasms
  • Advanced ovarian cancer
  • BRCA1 protein
  • BRCA2 protein
  • Poly(ADP ribose) polymerases
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Research SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteBeverly, Massachusetts  
Research SiteAlbany, New York  
Research SiteAbilene, Texas