Temozolomide + Tuvusertib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, temozolomide and M1774, in patients with advanced cancer that has spread. Temozolomide damages cancer cell DNA, while M1774 blocks growth enzymes. The goal is to find a more effective treatment for these patients.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot take proton-pump inhibitors (PPIs) while on M1774. H-2 receptor antagonists and antacids are allowed with timing restrictions around M1774 doses.
Is the combination of Temozolomide and Tuvusertib generally safe for humans?
What makes the drug Temozolomide + Tuvusertib unique for cancer treatment?
Temozolomide is unique because it is an oral drug that works by damaging the DNA of cancer cells, making it effective in treating various cancers, including those not typically treated with this drug. Its combination with Tuvusertib may offer a novel approach by potentially enhancing its effectiveness or overcoming resistance seen in some cancers.678910
What data supports the effectiveness of the drug Temozolomide + Tuvusertib for cancer?
Who Is on the Research Team?
Michael Cecchini
Principal Investigator
Yale University Cancer Center LAO
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tuvusertib orally once daily on days 1-7 and temozolomide orally once daily on days 1-5 of each 28-day cycle. Patients undergo CT scan, MRI, and blood sample collection throughout the trial.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up visits at 4 weeks, and then every 3 months for up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Temozolomide
- Tuvusertib
Temozolomide is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor