Trial intelligence / Profile preview

Olaparib and Ramucirumab in Metastatic Gastric and GEJ Adenocarcinoma

NCT03008278Phase 2

Key facts

Status: Completed
Start: Feb 2018
Primary completion: Jun 2023
Countries: 1
Sponsor: National Cancer Institute
Modality: Small Molecules

Drugs: olaparib
Conditions: Gastric carcinoma (GC)gastroesophageal junction adenocarcinomaesophageal carcinoma

Overview

Phase 2, open-label, single-arm trial of olaparib in Gastric carcinoma (GC), gastroesophageal junction adenocarcinoma and esophageal carcinoma, sponsored by National Cancer Institute. Primary endpoints: Dose Limiting Toxicity and Maximum Tolerated Dose at 28 days and Objective Response Rate at 2 years. Started Feb 2018; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment (olaparib, ramucirumab)
Patients receive olaparib PO BID on days 1-14 of each cycle and ramucirumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 14 days.

Who it enrols

Adult patients with metastatic or recurrent, unresectable gastric or GEJ adenocarcinoma who have progressed on or are intolerant to prior chemotherapy, with good performance status and adequate organ function. Excludes patients with prior exposure to ramucirumab, bevacizumab, or PARP inhibitors, untreated brain metastases, or significant cardiovascular/gastrointestinal conditions.

Endpoints

Primary

Dose Limiting Toxicity and Maximum Tolerated Dose28 days
Objective Response Rate2 years

Secondary

Progression-Free Survival2 years
Overall Survival2 years
Progression-Free Survival stratified by BROCA-HR Status6 months
Overall Survival stratified by BROCA-HR Status2 years
Count of Participants With Adverse Events2 years

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