Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments olaparib, paclitaxel, placebo
Phase phase 2
Target PARP
Sponsor AstraZeneca
Start date February 2010
End date May 2012
Trial size 267 participants
Trial identifier NCT01063517, D0810C00039

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Olaparib + paclitaxel
olaparib
100mg BID oral tablet continuous
paclitaxel Taxol
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
(Active Comparator)
paclitaxel + placebo
paclitaxel Taxol
iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle
placebo
100mg BID oral tablet to match olaparib tablet

Primary Outcomes

Measure
Progression Free Survival (PFS) in the Overall Study Population
time frame: Tumour assessments were carried out 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, assessed maximum up to 27 months
Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]
time frame: Tumour assessments are carried out 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, assessed maximum up to 27 months

Secondary Outcomes

Measure
Overall Survival (OS) in the Overall Study Population
time frame: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Overall Survival (OS) in ATM Negative Patients
time frame: Survival follow up from randomisation till death of the patient or till end of study in absence of death, assessed maximum up to 27 months
Objective Response Rate (ORR) in the Overall Study Population
time frame: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Objective Response Rate (ORR) in the ATM Negative Patients
time frame: Tumour assessments carried out at baseline, 28 days before randomisation then every 8 weeks until week 40, after week 40 assessments will be carried out every 16 weeks until objective disease progression, assessed maximum up to 27 months
Percentage Change in Tumour Size at Week 8 in the Overall Study Population
time frame: Tumour scans done at Baseline and week 8
Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients
time frame: Tumour scans done at Baseline and week 8
Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Fatigue Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Pain Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months
Time to Deterioration in QoL Anxiety Domain Score in the Overall Study Population
time frame: Questionnaire data collected at Baseline ie on or before date of randomisation, every 4 weeks post baseline, assessed maximum up to 27 months

Eligibility Criteria

Male or female participants from 18 years up to 150 years old.

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

Additional Information

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
Principal investigator Yung-Jue Bang, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.