Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01063517
First received: February 4, 2010
Last updated: July 12, 2013
Last verified: July 2013
  Purpose

To assess the efficacy of olaparib when given in combination with paclitaxel compared with paclitaxel alone as defined by progression-free survival (PFS), in all patients with recurrent and metastatic gastric cancer who progress following first-line therapy


Condition Intervention Phase
Gastric Cancer
Drug: olaparib
Drug: paclitaxel
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Efficacy (PFS) in the overall study population) [ 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 ] [ Designated as safety issue: Yes ]
  • Efficacy (PFS) in patients with tumours defined as HRD by loss of ATM protein ("ATM negative patients") [ 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of olaparib when given in combination with paclitaxel in patients with recurrent and metastatic gastric cancer who progress following first-line therapy [ Time Frame: Safety, adverse events and, laboratory findings at every visit ] [ Designated as safety issue: Yes ]
  • Assess the efficacy of olaparib when given in combination with paclitaxel compared to paclitaxel alone as defined by overall survival, response rate and percentage change in tumor size at Wk 8 in all patients with recurrent and metastatic gastric cancer [ Time Frame: % change in tumour size at 8 weeks ] [ Designated as safety issue: Yes ]
  • To conduct a preliminary assessment of the effects of olaparib when given in combination with paclitaxel on the time to deterioration of disease related symptom and HRQoL as assessed by the EORTC QLQ-C30 + -STO22 questionnaires [ Time Frame: Day 1, Day 29 and then every 4 weeks until discontinuation ] [ Designated as safety issue: Yes ]

Enrollment: 124
Study Start Date: February 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Olaparib + paclitaxel
Drug: olaparib
100mg BID oral tablet continuous
Drug: paclitaxel
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
Other Name: Taxol
Active Comparator: 2
paclitaxel + placebo
Drug: paclitaxel
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
Other Name: Taxol
Drug: Placebo
100mg BID oral tablet to match olaparib tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063517

Locations
Korea, Republic of
Research Site
Jeonju, Chonbuk, Korea, Republic of
Research Site
Daegu, Gyeongbuk, Korea, Republic of
Research Site
Anyang, Gyeonggi-do, Korea, Republic of
Research Site
Goyang, Gyeonggi, Korea, Republic of
Research Site
Seongnam, Gyeonggi, Korea, Republic of
Research Site
Jeonnam, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Yung-Jue Bang, MD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01063517     History of Changes
Other Study ID Numbers: D0810C00039
Study First Received: February 4, 2010
Last Updated: July 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Poly(ADP ribose)
polymerase (PARP)
Gastric cancer
olaparib
PARP inhibitor
ATM AZD2281
Ku0059436
Homologous Recombination deficiency (HRD)
Recurrent gastric cancer
metastatic gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014