Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: Placebo; Drug: Paclitaxel; Drug: Olaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01924533

D081BC00004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 525 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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525 participants in 2 patient groups, including a placebo group

Olaparib+ paclitaxel

Experimental group

Description:

olaparib + paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Olaparib

Placebo+paclitaxel

Placebo Comparator group

Description:

placebo+ paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Placebo