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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Placebo; Drug: olaparib; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063517

D0810C00039

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

1

Experimental group

Description:

Olaparib + paclitaxel

Treatment:

Drug: paclitaxel

Drug: olaparib

2

Active Comparator group

Description:

paclitaxel + placebo

Treatment:

Drug: Placebo

Drug: paclitaxel