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Anti-metabolites
Berzosertib + Gemcitabine for Ovarian Cancer
Phase 2
Waitlist Available
Led By Panagiotis A Konstantinopoulos
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
No known hypersensitivity or contraindication to the components of study treatment (M6620 [VX-970], gemcitabine)
Creatinine =< upper limit of institutional normal OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal (within 2 weeks prior to initiation of study treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.
Awards & highlights
Study Summary
This trial is testing a new drug, M6620, to see if it is more effective than standard treatment with gemcitabine hydrochloride alone in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Who is the study for?
This trial is for patients with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer that's resistant to platinum-based treatment and has recurred. Participants must have measurable disease, resolved prior therapy side effects (except hair loss), good physical health, and adequate organ function. They can't join if they've had certain recent treatments, brain metastases, uncontrolled illnesses, are pregnant/breastfeeding or HIV-positive on antiretrovirals.Check my eligibility
What is being tested?
The study compares the effectiveness of adding ATR kinase inhibitor M6620 (Berzosertib) to gemcitabine hydrochloride versus using gemcitabine alone in recurrent cancers. M6620 potentially enhances cell growth inhibition by blocking a key enzyme and may improve gemcitabine's efficacy.See study design
What are the potential side effects?
Potential side effects include reactions related to cell growth inhibition which could affect various organs and systems in the body. Specific side effects aren't listed but generally might involve fatigue, nausea, blood count changes or increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not allergic to the study drugs M6620 or gemcitabine.
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My kidney function is normal or nearly normal.
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All my side effects from previous treatments, except hair loss, are mild or gone.
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My cancer is high grade and resistant to platinum treatment.
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I have a tumor that can be measured with scans or exams.
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I am fully active or able to carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ae checks occurred on d1 and d8 of each cycle for up to 2 years and at the final treatment visit. patients who were removed from study treatment for unacceptable aes were followed until resolution/stabilization of the ae up to 3 years, or until death.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response
Number of Participants With Serious Adverse Events (SAEs)
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (gemcitabine, ATR kinase inhibitor M6620)Experimental Treatment3 Interventions
Patients receive gemcitabine hydrochloride as in Arm I and ATR kinase inhibitor M6620 IV over 60-90 minutes on days 2 and 9. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (gemcitabine hydrochloride)Active Control2 Interventions
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may crossover to Arm II.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Berzosertib
2021
Completed Phase 2
~80
Gemcitabine
2017
Completed Phase 3
~2070
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,083 Total Patients Enrolled
Panagiotis A KonstantinopoulosPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
2 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to the study drugs M6620 or gemcitabine.I am allergic to medications similar to M6620 or gemcitabine.My kidney function is normal or nearly normal.I can provide a specific type of tumor sample for testing.All my side effects from previous treatments, except hair loss, are mild or gone.It has been over 4 weeks since my last major surgery or radiation treatment.My cancer got worse during my first platinum-based chemotherapy.My cancer is high grade and resistant to platinum treatment.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I agree to use birth control during and 6 months after the study due to potential risks.I have undergone radiotherapy in the last 4 weeks.I have a tumor that can be measured with scans or exams.I've had limited treatment for my condition, avoiding specific drugs and pathways.I am fully active or able to carry out light work.I am not taking any strong medication that affects liver enzymes.I am not pregnant or breastfeeding.I am not HIV-positive or on antiretroviral therapy.I do not have brain metastases.I haven't had chemotherapy in the last 4 weeks or am recovered from its side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (gemcitabine hydrochloride)
- Group 2: Arm II (gemcitabine, ATR kinase inhibitor 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.
Is this study actively seeking participants at the present time?
"This trial is not presently seeking patients. It was initially announced on August 25th 2016 and last edited October 24 2022. If you are looking for similar trials, there are 3372 studies recruiting those with relapse and 456 research projects targeting Gemcitabine Hydrochloride that require participants."
Answered by AI
How many health care centers are currently facilitating this research project?
"The list of participating medical facilities currently includes Brigham and Women's Hospital in Boston, University of Pittsburgh Cancer Institute (UPCI) in Pennsylvania, Mayo Clinic located in Rochester Minnesota as well as 18 other locations."
Answered by AI
What are the regular applications of Gemcitabine Hydrochloride?
"Gemcitabine Hydrochloride is routinely prescribed for patients with small cell lung cancer, but it can also be beneficial in treating head and neck carcinoma, pancreatic adenocarcinoma of a localised nature, and cervical cancers."
Answered by AI
Are there any additional investigations of Gemcitabine Hydrochloride that have been undertaken?
"At present, 456 clinical studies are underway for Gemcitabine Hydrochloride with 134 of these trials in Phase 3. The majority of the research is conducted from Woolloongabba, Queensland yet 24687 sites around the world are conducting investigations into this drug's efficacy."
Answered by AI
Can you provide data on the safety and efficacy of Gemcitabine Hydrochloride?
"Despite the fact that clinical data supporting Gemcitabine Hydrochloride's efficacy is lacking, our team at Power still gave it a safety rating of 2 due to existing evidence suggesting its security."
Answered by AI
What is the current number of participants enrolled in this research?
"At this time, no further enrolment is needed for the mentioned clinical trial. It was first posted on August 25th 2016 and last updated on October 24th 2022. If other studies are being sought after, there are currently 3372 trials open to individuals with relapse and 456 studies admitting patients using Gemcitabine Hydrochloride as a treatment option."
Answered by AI
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