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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My organ and bone marrow functions meet the required levels.
Select...
I agree to undergo a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
The number of patients experiencing study drug-related toxicities.
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
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
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
~5380
Olaparib
2007
Completed Phase 4
~2140
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,864 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,021 Total Patients Enrolled
Katherine Bever, MDPrincipal InvestigatorJohns Hopkins Medical Institution
1 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have cancer spread to my brain or spinal cord and need treatment.I agree to undergo a biopsy.I am not pregnant or breastfeeding.I have had pneumonitis treated with steroids or currently have it.I am 18 years old or older.I am currently on medication for an uncontrolled infection.I have a serious ongoing health condition that is not under control.I am fully active or restricted in physically strenuous activity but can do light work.I had radiotherapy less than 2 weeks before starting the study treatment.I have another cancer that is getting worse and needed treatment in the last year.My cancer is in an advanced stage in my stomach or where my esophagus meets my stomach.I have been treated with paclitaxel or a PARP inhibitor without my cancer getting worse within 6 months.My cancer is in an advanced stage in my stomach or where my esophagus meets my stomach.I have had a transplant of tissue, organ, or bone marrow from another person.I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.I am 18 years old or older.I have not received a live vaccine in the last 30 days.I have had one treatment for my advanced disease and it did not work.I do not have HIV or hepatitis B or C.I haven't had any cancer treatment or experimental drugs in the last 2 weeks.I am a woman who can have children and my pregnancy test is negative.I am a woman who can have children and my recent pregnancy test was positive.I am a woman who can have children and my pregnancy test is negative.You are expected to live for at least 3 more months.I have been diagnosed with an immune system disorder.My organ and bone marrow functions meet the study's requirements.I am currently taking medication that strongly affects liver enzyme activity.I need treatment for cancer that affects my whole body or a specific area.I need extra oxygen every day.I have had one treatment for my advanced disease and it did not work.My organ and bone marrow functions meet the required levels.I agree to undergo a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 - Measurable Disease
- Group 2: Arm 2: Cohort 2-Unmeasurable Disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What therapeutic purpose does Paclitaxel typically serve?
"Paclitaxel is typically prescribed to treat individuals suffering from inoperable melanoma. It may also be effective for those with a heightened risk of recurrence or microsatellite instability high diseases."
Answered by AI
Is there room to enroll more participants in this research initiative?
"Correct. The clinicaltrials.gov database reveals that the study, initially unveiled on July 31st 2020 is presently seeking volunteers. 1 medical site needs to recruit 36 participants for this experiment."
Answered by AI
What other research efforts have been conducted with Paclitaxel?
"Presently, there are 1835 clinical trials in progress for Paclitaxel with 337 of them being Phase 3. This treatment is primarily studied at locations within Shanghai but can also be found across the globe with a total of 79525 trial sites."
Answered by AI
What is the potential risk of Paclitaxel to human health?
"There is limited data that confirms Paclitaxel's safety, so it was assigned a rating of 2."
Answered by AI
How many volunteers are being enlisted for this clinical trial?
"Affirmative, clinicaltrials.gov provides information stating that this experiment is actively enrolling volunteers. It was initially advertised on 31st July 2020 and the details have been updated as recently as 3rd March 2022. 36 individuals need to be selected from a single medical centre for participation in the trial."
Answered by AI
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