Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Recurrence

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

olaparib

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

paclitaxel

100mg BID oral tablet to match olaparib tablet

Placebo

Jane Robertson, BSc, MBCHB, MD

Yung-Jue Bang, MD

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.

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

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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.

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.

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).

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

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

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

Time calculated from randomisation till worsening of nausea \& vomiting domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

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

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

Time calculated from randomisation till worsening of eating restriction domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

Time calculated from randomisation till worsening of stomach pain domain score based on European Organisation for Research and Treatment of Cancer (EORTC) questionnaire data

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

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

AstraZeneca

OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD

PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD

Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.

Olaparib+Paclitaxel

Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.

Placebo+Paclitaxel

Total

Age, Continuous

< 50 years

>=50 to <65 years

>= 65 years

Age, Customized

Sex: Female, Male

Asian

Other

Race/Ethnicity, Customized

Negative

Positive

Ataxia-Telangiectasia Mutation (ATM) protein testing

ATM status

Anitra Fielding

The analysis was performed using a Cox proportional hazards model with factors for treatment group, ATM status and gastrectomy (full, partial, none).

Full analysis set including all randomised patients

Progression Free Survival (PFS) in the Overall Study Population

The analysis was performed using a Cox proportional hazards model with factors for treatment group and gastrectomy (full, partial, none).

Full analysis set including randomised ATM negative patients

Progression Free Survival (PFS) in Patients With Tumours Defined as Homologous Recombination Deficient by Loss of Ataxia-Telangiectasia Mutation (ATM) Protein [ATM Negative Patients]

Overall Survival (OS) in the Overall Study Population

Overall Survival (OS) in ATM Negative Patients

Evaluable for response population - randomised patients having measurable disease at baseline.

Objective Response Rate (ORR) in the Overall Study Population

Evaluable for response population ATM negative patients - randomised ATM negative patients having measurable disease at baseline.

Objective Response Rate (ORR) in the ATM Negative Patients

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

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

Randomised patients having global score calculated at baseline and at least one post baseline visit

Time to Deterioration in Global Quality of Life (QoL) Score in the Overall Study Population

Randomised patients having fatigue score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Fatigue Score in the Overall Study Population

Randomised patients having nausea \& vomiting domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Nausea & Vomiting Domain Score in the Overall Study Population

Randomised patients having pain domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Pain Domain Score in the Overall Study Population

Randomised patients having dysphagia domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Dysphagia Domain Score in the Overall Study Population

Randomised patients having eating restriction domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Eating Restriction Domain Score in the Overall Study Population

Randomised patients having stomach pain domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Stomach Pain Domain Score in the Overall Study Population

Randomised patients having reflux domain score calculated at baseline and at least one post baseline visit

Time to Deterioration in QoL Reflux Domain Score in the Overall Study Population

Randomised patients having anxiety domain score calculated at baseline and at least one post baseline visit

Spots Global Cancer Trial Database for Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

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