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Chemotherapy + Berzosertib for Ovarian Cancer
Study Summary
This trial is testing the combination of gemcitabine hydrochloride, berzosertib, and carboplatin to treat ovarian, primary peritoneal, or fallopian tube cancer that has returned and spread.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I can take care of myself but might not be able to do heavy physical work.I will not receive bevacizumab as part of this study's treatment.My cancer is a specific type that has spread and cannot be cured with surgery or radiation.I have a tumor that can be measured with scans or exams.You are expected to live for at least 6 more months.Your bilirubin levels are within the normal range for your age and gender.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer did not respond to platinum-based treatment or it came back after such treatment.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects, except for hair loss.I am not pregnant or breastfeeding.I have had no more than two treatments that included platinum-based drugs.Your platelet count should be at least 100,000 per microliter.I am not taking strong drugs that affect liver enzyme CYP3A4.I do not have Li Fraumeni syndrome.I have cancer that responded to platinum therapy and can provide tissue samples.I have no allergies to M6620, carboplatin, gemcitabine, or similar drugs.I am an adult.I have been treated with gemcitabine before.Your white blood cell count is 3,000 or higher.You have enough white blood cells called neutrophils.My kidney function is normal or nearly normal.Women who can have babies must have a negative pregnancy test.I do not have brain metastases.Your liver enzymes (AST and ALT) are not more than two times the normal level.You are taking any other experimental medications.
- Group 1: Treatment (carboplatin, gemcitabine hydrochloride, VX-970)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Are any new participants being recruited for this trial at present?
"Indications from clinicaltrials.gov indicate that this medical trial is not presently recruiting participants, despite first being posted on November 4th 2016 and last updated December 2nd 2022. However, there are currently 5009 other studies actively enrolling patients in various locations."
How many test subjects have been accepted for participation in this trial?
"As of the latest update on December 2nd 2022, this clinical trial is not actively enrolling participants. However there are numerous other studies underway with 3938 trials for fallopian tube carcinoma and 1071 research initiatives into Berzosertib that may be suitable for prospective patients."
What conditions is Berzosertib commonly prescribed to treat?
"Berzosertib is primarily utilized to manage advanced endometrial cancer. Additionally, this medication may be useful for treating melanoma and various lymphomas as well as non-Hodgkin's lymphoma and late-stage sarcomas."
Are there any precedent investigations involving Berzosertib?
"A total of 1071 clinical trials concerning Berzosertib are in operation worldwide, with 323 of them currently at Phase 3. Shanghai is the epicentre for these investigations, yet other cities have also been enlisted to join this effort."
Are there any known dangers associated with Berzosertib usage?
"The safety profile of Berzosertib was given a score of 1 as this is Phase 1 clinical trial, meaning that there are limited data points to support its efficacy and safety."
What is the desired outcome of this research endeavor?
"The primary goal of this clinical trial, assessed over the course of up to 28 days, is to monitor adverse events. Secondary aims include estimating progression-free survival (PFS) with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and Kaplan-Meier method; determining confirmed response rate by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; and measuring overall survival (OS) via Kaplan-Meier method analysis."
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