Trial Information
A Randomised, Double Blinded, Multicentre Phase II Study to Assess the Efficacy of Olaparib (AZD2281, KU-0059436) in Combination With Paclitaxel Versus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer Who Progress Following First-line Therapy
Inclusion Criteria:
- Recurrent or metastatic gastric cancer that has progressed following first
line-therapy
- Confirmed ATM protein status by IHC archival tumour sample
- At least one lesion (measurable and/or non-measurable) that can be accurately
assessed by imaging (CT/MRI) at baseline and follow up visits
Exclusion Criteria:
- More than one prior chemotherapy regimen for the treatment of gastric cancer in the
metastatic or recurrent setting
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients with second primary cancer, except; adequately treated non melanoma skin
cancer, curatively treated in situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for >5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Efficacy (PFS) in the overall study population)
Outcome Time Frame:
Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1
Safety Issue:
Yes
Principal Investigator
Jane Robertson, BSc, MBCHB, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Korea: Food and Drug Administration
Study ID:
D0810C00039
NCT ID:
NCT01063517
Start Date:
February 2010
Completion Date:
May 2012
Related Keywords:
- Gastric Cancer
- Poly(ADP ribose)
- polymerase (PARP)
- Gastric cancer
- olaparib
- PARP inhibitor
- ATM AZD2281
- Ku0059436
- Homologous Recombination deficiency (HRD)
- Recurrent gastric cancer
- metastatic gastric cancer
- Stomach Neoplasms