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

AstraZeneca124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Gastric Cancer

Interventions

olaparibDRUG

100mg BID oral tablet continuous

paclitaxelDRUG

iv infusion 80mg/m2 on Day 1, 8 and 15 of a 28 day cycle

PlaceboDRUG

100mg BID oral tablet to match olaparib tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Goyang-si, South Korea

Research Site

Jeonnam, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Outcomes

Primary Outcomes

Progression Free Survival (PFS) in the Overall Study Population

PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.

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]

PFS is defined as the time from randomisation till objective progression or death. In absence of progression or death, the time is calculated from randomisation till last evaluable scanning visit.

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

Overall Survival (OS) in the Overall Study Population

Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.

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

Overall survival is defined as the duration from randomisation till death. In absence of death, the time is calculated from randomisation till the date subject last known to be alive.

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

Data from ClinicalTrials.gov

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Research Site

Seoul, South Korea

Research Site

Taegu, South Korea

Objective Response Rate (ORR) in the Overall Study Population

Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

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

Objective response rate is the proportion of ATM negative patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

Percentage Change in Tumour Size at Week 8 in the Overall Study Population

Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)

Time frame: Tumour scans done at Baseline and week 8

Percentage Change in Tumour Size at Week 8 in the ATM Negative Patients

Percentage change in tumour size from baseline to Week 8 calculated as 100 X (week 8 tumour size - baseline tumour size) / (baseline tumour size)

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 calculated from randomisation till worsening of Global QoL score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data