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Alkylating agents
Temozolomide + Tuvusertib for Cancer
Phase 1 & 2
Recruiting
Led By Michael Cecchini
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial studies a combination of drugs to treat cancer that has spread and may stop or slow its growth.
Who is the study for?
Adults with advanced metastatic cancer, particularly colorectal cancer that's stable and has not spread widely after certain treatments. They must have tried all beneficial therapies or be unable to tolerate them. Those with specific blood levels, organ function, and no severe allergies to trial drugs can join. Pregnant women and individuals with uncontrolled illnesses or recent adverse reactions from past cancer treatments are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Temozolomide (a DNA-damaging agent) and M1774 (an enzyme blocker) on patients with advanced cancers to see if this combo is safer or more effective than current treatments. It includes imaging tests like MRI/CT scans and biopsies for monitoring responses.See study design
What are the potential side effects?
Potential side effects include damage to organs where enzymes are blocked by M1774, allergic reactions similar to those seen in other chemotherapy agents like dacarbazine, fatigue from anemia due to temozolomide, digestive issues affecting medication absorption, and possible heart rhythm problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity and the maximum tolerated dose
Secondary outcome measures
Objective response rate (ORR)
Overall survival (OS)
Progression free survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tuvusertib, temozolomide)Experimental Treatment6 Interventions
Patients receive tuvusertib PO QD) on days 1-7 and temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and MRI as well as collection of blood samples throughout the trial. Patients also undergo a biopsy at baseline and may undergo one on study and/or at time of progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Temozolomide
2010
Completed Phase 3
~1930
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,383 Total Patients Enrolled
Michael CecchiniPrincipal InvestigatorYale University Cancer Center LAO
1 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer can be measured on scans according to specific criteria.My cancer is advanced and has spread, confirmed by lab tests.My brain scans show no cancer growth 4 weeks after treatment for brain metastases.I have tried all treatments for my cancer that could help, or I cannot tolerate them.My cancer is either MGMT positive or is a type where TMZ is standard treatment.I cannot stop taking my acid reflux medication while on M1774.I have had extensive radiation therapy affecting more than 30% of my bone marrow.I have recovered from side effects of previous cancer treatments, except for hair loss and nerve issues.I can take care of myself but might not be able to do active work.I have a history of ataxia telangiectasia.I do not have any unmanaged ongoing illnesses.I cannot take pills by mouth or have stomach issues affecting medication absorption.I have another cancer that won't affect this treatment's safety or results.My colorectal cancer is stable and has a specific genetic feature identified in tests.I am allergic to drugs similar to M1774 or temozolomide.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tuvusertib, temozolomide)
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 still opportunities for patients to enrol in this clinical trial?
"Affirmative. Per the clinicaltrials.gov repository, this medical experiment is searching for 58 volunteers from one center since its initial posting on September 7th 2023 and last modification on July 4th 2023."
Answered by AI
How many participants are being recruited for this experiment?
"Affirmative, there is a listing on clinicaltrials.gov that confirms the active recruitment process for this medical trial which was first published in September of 2023 and recently revised on July 4th of 2023. 58 volunteers are needed to partake in the experiment at one single location."
Answered by AI
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