Olaparib for GastroEsophageal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Colorado Health, Aurora, CO
GastroEsophageal Cancer+2 More
Olaparib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is an open-label, phase II study with a safety lead-in to assess the response rate of induction olaparib and stereotactic beam radiotherapy (SBRT) followed by combination olaparib/pembrolizumab in patients with metastatic gastric and GEJ cancers after at least one of therapy.

Eligible Conditions

  • GastroEsophageal Cancer
  • Malignant Neoplasm of Stomach

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4 years

4 years
Disease Control Rate (DCR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Duration of Response (DOR) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 during concurrent SBRT/olaparib
Objective Response Rate (ORR) of unirradiated tumors
Overall Survival (OS) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.
Progression Free Survival (PFS) of Total Cohort and HRD (Homologous Recombination Deficiency) versus HR (Homologous Recombination) proficient.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

HR proficient cohort
1 of 2
HR deficient cohort
1 of 2
Experimental Treatment

26 Total Participants · 2 Treatment Groups

Primary Treatment: Olaparib · No Placebo Group · Phase 2

HR proficient cohortExperimental Group · 3 Interventions: Pembrolizumab, Olaparib, Stereotactic Body Radiation Therapy · Intervention Types: Drug, Drug, Radiation
HR deficient cohortExperimental Group · 3 Interventions: Pembrolizumab, Olaparib, Stereotactic Body Radiation Therapy · Intervention Types: Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2950
Olaparib
2017
Completed Phase 4
~2060
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years
Closest Location: University of Colorado Health · Aurora, CO
Photo of aurora  1Photo of aurora  2Photo of aurora  3
2009First Recorded Clinical Trial
1 TrialsResearching GastroEsophageal Cancer
13 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a primary tumor or a single metastatic site amenable to radiation in the stomach, esophagus, liver, lungs, pancreas, thoracic/abdominal LNs, or soft tissues.
You are eligible for this study if you have been diagnosed with Hodgkin's lymphoma and have not received treatment for the disease.
You are at least 18 years of age.
Patients with germline deleterious mutations may have been identified at any time point prior to inclusion in the protocol and do NOT need to have this genetic testing repeated regardless of time frame and intervening therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.