Your session is about to expire
← Back to Search
PARP Inhibitor
Berzosertib + Irinotecan for Gastric Cancer
Phase 2
Waitlist Available
Led By Jordan D Berlin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam.
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 60%).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is studying how well berzosertib and irinotecan work in treating patients with gastric or gastroesophageal junction cancer.
Who is the study for?
This trial is for adults over 18 with progressive, metastatic, or unresectable gastric or gastroesophageal junction cancer that has a TP53 mutation. Participants must have tried at least two systemic therapies and meet certain health criteria (like blood cell counts). Women of childbearing age and men with partners of childbearing age must use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of combining berzosertib, which blocks enzymes needed for tumor growth, with irinotecan, a chemotherapy drug that kills or stops the spread of cancer cells. The goal is to see if this combination works better than irinotecan alone in treating these cancers.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss (alopecia), low blood cell counts leading to increased infection risk or bleeding problems. Berzosertib's side effects are not fully known but could involve similar reactions due to its role in blocking cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured with imaging or physical exam.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I agree to use effective birth control during and 6 months after the study if I can have children.
Select...
I am 18 years old or older.
Select...
My kidney function is good enough for the trial.
Select...
My cancer is a type that started in the stomach or where the stomach meets the esophagus, and it cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response criteria
Secondary outcome measures
Duration of responses (DOR)
Overall survival (OS)
Progression-free survival (PFS)
+1 moreOther outcome measures
DOR in sub-cohorts based on first-line platinum sensitivity
ORR in sub-cohorts based on first-line platinum sensitivity
OS in sub-cohorts based on first-line platinum sensitivity
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (irinotecan and M6620)Experimental Treatment5 Interventions
Patients receive irinotecan IV over 90 minutes and berzosertib IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo endoscopic or CT assisted biopsy and MRI on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Irinotecan
2017
Completed Phase 4
~2680
Berzosertib
2021
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,135 Total Patients Enrolled
Jordan D BerlinPrincipal InvestigatorYale University Cancer Center LAO
Satya DasPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have untreated or symptomatic brain metastases.I haven't had any cancer besides local ones in the past 3 years.I still have side effects from cancer treatment that are not hair loss.I am willing to have a biopsy for study purposes, unless my doctor says it's unsafe.You are not currently taking any experimental or not yet approved medications.I have a tumor that can be measured with imaging or physical exam.I am mostly self-sufficient and can carry out daily activities.I agree to use effective birth control during and 6 months after the study if I can have children.I am not taking strong medication that affects how my body processes certain cancer drugs.I do not have any serious illnesses that would stop me from following the study's requirements.I am HIV-positive with an undetectable viral load and my medication does not interact with CYP3A4.My cancer has worsened after two treatments, and I've had specific therapies based on my cancer type.I am 18 years old or older.My kidney function is good enough for the trial.My cancer has a specific TP53 mutation confirmed by a certified lab test.I have been treated with irinotecan before.You have had allergic reactions to drugs similar to M6620 or irinotecan in the past.I am eligible regardless of my gender, race, or ethnicity.I have early stage stomach cancer that has not been treated or can be surgically removed.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I am not pregnant or breastfeeding.My cancer is a type that started in the stomach or where the stomach meets the esophagus, and it cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (irinotecan and M6620)
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.
Are there multiple healthcare facilities in the U.S. conducting this clinical research?
"This clinical trial is accepting patients at the University of Kansas Hospital-Westwood Cancer Center in Westwood, KS; Ohio State University Comprehensive Cancer Center in Columbus, OH; and University of Oklahoma Health Sciences Centre in Oklahoma City, OK. In addition, there are 30 other recruitment sites throughout the US."
Answered by AI
Has Berzosertib been authorized for use by the Food and Drug Administration?
"The safety of Berzosertib has been rated a 2 due to the Phase 2 trial status. This implies that while some data exists in regards to its safety, there is currently no proof attesting to its efficacy."
Answered by AI
What additional research has been conducted involving Berzosertib?
"Berzosertib was first examined at Mayo Clinic in Rochester over 2 decades ago, and has since been the subject of 570 completed studies. Currently there are 276 active trials taking place, with a large concentration around Westwood, Kansas."
Answered by AI
What medical conditions is Berzosertib typically employed to address?
"Berzosertib is a viable therapeutic option for the treatment of malignant neoplasms in pancreas, as well as secondary tumours, gastric cancer and rhabdomyosarcoma."
Answered by AI
Are there any vacancies for this research endeavor at present?
"According to clinicaltrials.gov, this medical research project is still recruiting volunteers and has been open since June 30th 2020 with the latest update being made on November 11th 2022."
Answered by AI
How many individuals have been included in the research for this clinical trial?
"This clinical trial requires 18 participants that meet the eligibility criteria. Individuals in search of this research opportunity can find sites at University of Kansas Hospital-Westwood Cancer Center in Westwood, Kansas and Ohio State University Comprehensive Cancer Center in Columbus, Ohio."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger