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M1774 + Niraparib for Solid Tumors
Study Summary
This trial is testing a new drug, M1774, to see if it is safe and effective when used alone or with another drug, niraparib.
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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- My blood, liver, and kidney functions meet the required levels.I haven't had a heart attack, severe chest pain, heart failure, or heart surgery in the last 6 months.My cancer has specific genetic mutations in ARID1A, ATRX, DAXX, or ATM.I am not pregnant or breastfeeding.My heart's electrical cycle is longer than normal and not due to electrolyte issues.My side effects from previous cancer treatments are mild or gone.I have a genetic condition that affects how my body repairs DNA.My brain metastases are treated, I have no symptoms, and I haven't used steroids in over 28 days.I have not received a live vaccine in the last 30 days.I have previously used ATR or CHK1 inhibitors.I haven't had major surgery, except for a biopsy, in the last 4 weeks or I've fully recovered from it.My advanced cancer does not respond to standard treatments.I haven't taken any experimental drugs in the last 28 days.I weigh less than 77 kg or my platelet count is below 150,000/mm^3.I have a history of AML, MDS, or prostate cancer.I do not have cancer cells in the lining of my brain and spinal cord.I weigh at least 77 kg and my platelet count is 150,000 or higher.I am fully active and can carry on all pre-disease activities without restriction.
- Group 1: Part B1: Combination Therapy Dose Finding
- Group 2: Part A1: Monotherapy Dose Escalation
- Group 3: Part A4: Japan Dose Confirmation Monotherapy
- Group 4: Part A5: China Dose Confirmation Monotherapy
- Group 5: Part A3 - Monotherapy Expansion
- Group 6: Part A2 - Preliminary Food Effect Assessment
- 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
Have there been any prior investigations concerning M1774?
"At the moment, 99 medical trials are focusing on M1774 and 13 of them have entered Phase 3. Washington, District of Columbia is one such location undertaking these tests however a total of 2817 sites globally are conducting research into this drug."
Is this study a groundbreaking exploration of its kind?
"Since 2016, Myriad Genetics has undertaken numerous trials for M1774. After its initial study in which 733 participants were involved, the drug was approved to enter Phase 3 testing. Presently 99 experiments are being conducted worldwide with sites located across 485 cities and 49 nations."
Is recruitment for participants open for this experiment?
"According to the clinicaltrials.gov database, this trial is actively recruiting candidates with its first post dated December 20th 2019 and last edit on April 27th 2022."
Has the Food and Drug Administration sanctioned M1774?
"The safety of M1774 is estimated to be a 1 since it is currently undergoing the first stage of clinical trials, which limits our understanding of its efficacy and security."
What is the capacity of this research project in terms of participant numbers?
"Affirmative. Clinicaltrials.gov indicates that this trial is presently attempting to recruit patients, with the first posting dating back to December 20th 2019 and the most recent update on April 27th 2022. A total of 130 individuals are needed from 2 separate centres."
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