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Poly ADP-ribose polymerase (PARP) inhibitor

Paclitaxel + Pembrolizumab + Olaparib for Gastric Cancer

Phase 2
Recruiting
Led By Katherine Bever, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must agree to have a biopsy
Age ≥18 years
Must not have
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Require any antineoplastic therapy
Woman who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to see if they are safe and effective in treating advanced gastric cancer in people who have already tried other treatments.

Who is the study for?
Adults over 18 with advanced gastric or gastroesophageal cancer, who have failed one prior therapy and have a measurable lesion. They must be in good physical condition (ECOG 0-1), not pregnant, willing to use birth control, and able to consent. Excluded are those with brain metastases, certain allergies, recent other treatments or vaccines, active infections like HIV/hepatitis B/C, severe illnesses or conditions that could affect study participation.
What is being tested?
The trial is testing the combination of Paclitaxel (a chemotherapy drug), Olaparib (a PARP inhibitor) and Pembrolizumab (an immunotherapy drug) in patients who've had previous treatment for advanced Gastric Cancer. The goal is to assess safety and how well this combo works against the cancer.
What are the potential side effects?
Possible side effects include allergic reactions to drugs; blood disorders; fatigue; nausea; increased risk of infection due to immune system suppression by Pembrolizumab; potential organ damage from Olaparib's effect on DNA repair processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to undergo a biopsy.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is in an advanced stage in my stomach or where my esophagus meets my stomach.
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My cancer is in an advanced stage in my stomach or where my esophagus meets my stomach.
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I am 18 years old or older.
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I have had one treatment for my advanced disease and it did not work.
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I am a woman who can have children and my pregnancy test is negative.
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My organ and bone marrow functions meet the study's requirements.
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I have had one treatment for my advanced disease and it did not work.
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My organ and bone marrow functions meet the required levels.
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I agree to undergo a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer spread to my brain or spinal cord and need treatment.
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I am not pregnant or breastfeeding.
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I have had pneumonitis treated with steroids or currently have it.
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I have had a transplant of tissue, organ, or bone marrow from another person.
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I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.
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I do not have HIV or hepatitis B or C.
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I am currently on medication for an uncontrolled infection.
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I have a serious ongoing health condition that is not under control.
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I have been diagnosed with an immune system disorder.
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I am currently taking medication that strongly affects liver enzyme activity.
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I need treatment for cancer that affects my whole body or a specific area.
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I need extra oxygen every day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Secondary study objectives
The number of patients experiencing study drug-related toxicities.

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Headache
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 1 - Measurable DiseaseExperimental Treatment3 Interventions
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Group II: Arm 2: Cohort 2-Unmeasurable DiseaseExperimental Treatment3 Interventions
All Participants will receive Paclitaxel, Olaparib and Pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Olaparib
2007
Completed Phase 4
~2190
Pembrolizumab
2017
Completed Phase 3
~3130

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
571 Previous Clinical Trials
33,318 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,032 Previous Clinical Trials
5,189,764 Total Patients Enrolled
Katherine Bever, MDPrincipal InvestigatorJohns Hopkins Medical Institution
1 Previous Clinical Trials
17 Total Patients Enrolled

Media Library

Olaparib (Poly ADP-ribose polymerase (PARP) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04209686 — Phase 2
Gastric Cancer Research Study Groups: Cohort 1 - Measurable Disease, Arm 2: Cohort 2-Unmeasurable Disease
Gastric Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT04209686 — Phase 2
Olaparib (Poly ADP-ribose polymerase (PARP) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209686 — Phase 2
~15 spots leftby Apr 2028
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