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

AstraZeneca logo

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

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

Trial contacts and locations

57

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Data sourced from clinicaltrials.gov

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