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Enzyme Inhibitor
Tuvusertib for Refractory Prostate Cancer
Phase 2
Recruiting
Led By Jacob Orme
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 from registration date
Awards & highlights
Study Summary
This trial tests a new drug to treat prostate cancer that doesn't respond to other treatments, linked to a gene mutation. The drug could stop cancer growth by blocking enzymes.
Who is the study for?
This trial is for adults with hard-to-treat prostate cancer that has a specific SPOP gene mutation. Participants must have measurable disease, be on hormone therapy or surgically castrated, and have adequate organ function. People with controlled HIV or hepatitis are eligible; those with certain heart conditions may join after assessment. Women of childbearing potential and men must agree to use contraception.Check my eligibility
What is being tested?
The trial tests M1774's effectiveness in shrinking or stabilizing refractory SPOP-mutant prostate cancer by inhibiting enzymes needed for tumor cell growth. It involves various assessments like biospecimen collection, imaging (ultrasound, CT, MRI, PET), and biopsy to monitor the treatment's impact.See study design
What are the potential side effects?
While not explicitly listed here, side effects likely include reactions related to enzyme inhibition which could affect cell growth in the body leading to fatigue, gastrointestinal issues, blood count changes and potentially impact organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from registration date
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from registration date
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate
Secondary outcome measures
Incidence of adverse events (AE)
Overall Survival
Progression Free Survival (PFS)
Other outcome measures
Overall SPOP-driven gene signature changes
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (tuvusertib)Experimental Treatment7 Interventions
Patients receive tuvusertib PO QD on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, MRI, CT, PET/MRI, PET/CT or U/S and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound Imaging
2018
Completed Phase 4
~730
Biospecimen Collection
2004
Completed Phase 2
~1700
Positron Emission Tomography
2008
Completed Phase 2
~2240
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,421 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Jacob OrmePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chronic hepatitis B but it's under control with treatment.My partner agrees to use birth control.I have recovered from side effects of previous cancer treatments, except for hair loss.I cannot stop taking proton pump inhibitors or certain other medications.I have brain metastases but don't need immediate treatment for them.My testosterone levels are low due to hormone therapy or surgery.I have been treated with specific prostate cancer medications before.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.My brain scans show no worsening after treatment for brain metastases.I have a history or symptoms of heart disease and need a heart function assessment.My prostate cancer has SPOP mutations.I have another cancer that won't affect this treatment's safety or results.I have at least one tumor that can be measured.I am HIV positive, on treatment, and my viral load is undetectable.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (tuvusertib)
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.
Can new participants still join this clinical trial?
"According to the information from clinicaltrials.gov, this medical study is open for patient recruitment at present. It was first posted on April 27th 2024 and its most recent update came on August 12th 2023."
Answered by AI
What is the enrolment quota for this investigation?
"Yes, the information on clinicaltrials.gov suggests that this experiment is actively seeking participants. It was first listed on April 27th 2024 and most recently updated August 12th 2023. The trial requires a total of twenty individuals to be recruited from one location."
Answered by AI
Has tuvusertib been granted official sanction by the FDA?
"We evaluated the safety of Tuvusertib on a scale from 1 to 3 and assigned it a 2. This is because this Phase 2 trial has evidence that supports its security, though none indicating potency."
Answered by AI
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