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Phase I

A Phase 1/2 Study of Olaparib in Combination With Ramucirumab in Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma (10017760)

  • Study HIC#:2000021407
  • Last Updated:07/15/2021

This pilot phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body, has come back, or cannot be removed by surgery. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as ramucirumab, may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer.

  • Start Date11/29/2017
  • End Date06/29/2021

Trial Purpose and Description

PRIMARY OBJECTIVES:

I. To determine the safe dose of olaparib with ramucirumab, but not to exceed olaparib dose of 300 mg twice daily (tablet formulation). (Phase I) II. To determine the efficacy of olaparib plus ramucirumab as measured by the objective response rate (ORR). (Phase II).

SECONDARY OBJECTIVES:

I. To estimate median progression-free survival (PFS). II. To estimate median overall survival (OS). III. To measure the prevalence of the BROCA-HR biomarker in our study population.

IV. To determine toxicity of olaparib and ramucirumab combination. V. To evaluate the effects of this regimen on quality of life scores by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).

TERTIARY OBJECTIVES:

I. To assess the correlation between the Myriad homologous recombination deficiency (HRD) assay results, the signature 3 status, and mutations in BROCA-HR panel.

II. To evaluate the association between findings from BROCA-HR panel, the Myriad HRD assay, and signature 3 results with response to therapy.

III. To determine results of immunoassay for poly-ADP-ribosylated (PAR) substrates in tumor tissue.

IV. To create a PDX model to study DNA repair in gastric tumors treated with PARP inhibitors (PARPi) from both pre-treatment biopsy and repeat biopsy after 16 weeks of treatment.

V. Biobank additional tumor tissue for future genomic analysis. VI. Biobank peripheral blood for future genomic analysis and assessment of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE: This is a phase I, dose-escalation study of olaparib followed by a phase II study.

Patients receive olaparib orally (PO) twice daily (BID) on days 1-14 and ramucirumab intravenously (IV) over 60 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

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