Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

Thank you

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

Name

Location