Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments olaparib, paclitaxel, placebo
Phase phase 3
Target PARP
Sponsor AstraZeneca
Start date September 2013
End date April 2016
Trial size 644 participants
Trial identifier NCT01924533, D081BC00004

Summary

This study is a phase III, multi-centre study of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with advanced gastric cancer who have progressed following first-line therapy. Patients will be from China, Japan , Korea and Taiwan.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
olaparib + paclitaxel
olaparib
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.
paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
(Placebo Comparator)
placebo+ paclitaxel
paclitaxel
IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
placebo
Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.

Primary Outcomes

Measure
Overall survival
time frame: Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years

Secondary Outcomes

Measure
Progression-Free Survival (PFS)
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, assessed up to 3 years
Objective Response Rate (ORR)
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, assessed up to 3 years
To investigate plasma exposure to olaparib in a subset of olaparib dosed patients in the presence of paclitaxel and assess the impact of previous gastric surgery on that exposure
time frame: Blood samples (2 mL) for determination of olaparib in plasma will be taken at the times on pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours after first dose of study
Time to deterioration of Health Related Quality of Life (HRQoL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 item module (QLQ-C30) global HRQoL scale
time frame: Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years
Assessment of Adverse events (AEs)
time frame: Assessed up to 3 years
Assessments of physical examination, vital signs (including blood pressure (BP) and pulse)
time frame: Assessed up to 3 years
Assessment of electrocardiogram (ECG)(if clinically indicated)
time frame: Assessed up to 3 years
Assessment of laboratory findings including clinical chemistry, haematology and urinalysis (if clinically indicated)
time frame: Assessed up to 3 years
Time to response
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, assessed up to 3 years
Duration of response
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, assessed up to 3 years

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

Inclusion Criteria: - Advanced gastric cancer (including GEJ) that has progressed following first-line therapy. - Patients must be ≥18 years of age. Age ≥20 if Japanese - Provision of tumour sample (from either a resection or biopsy). - At least one lesion (measurable and/or non-measurable) that can be accurately assessed by imaging (CT/MRI) at baseline and following up visits. Exclusion Criteria: - More than one prior chemotherapy regimen (except for adjuvant/neoadjuvant chemotherapy with more than 6 month wash out period) for the treatment of gastric cancer in the advanced setting. - Any previous treatment with a Polyadenosine 5'-diphosphoribose [poly-(ADP-ribose)] polymerisation (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. - Human Epidermalgrowth Factor Receptor-2 (HER2) positive patients.

Additional Information

Official title A Randomized, Double-blinded, Placebo Controlled, Multicentre Phase III Study to Assess the Efficacy and Safety of Olaparib (AZD2281) in Combination With Paclitaxel, Compared to Placebo in Combination With Paclitaxel, in Asian Patients With Advanced Gastric Cancer (Including the Gastro-oesophageal Junction) Who Have Progressed Following First Line Therapy
Principal investigator Yung-Jue Bang, MD
Description A randomized, double-blinded, multicentre phase III study to access the efficacy and safety of olaparib in combination with paclitaxel, compared with placebo in combination with paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal junction) who have progressed following first line therapy.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.