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Histone Methyltransferase Inhibitor
Tulmimetostat for Skin Cancer
Phase 1
Recruiting
Led By Neha Mehta-Shah, M.D.
Research Sponsored by Washington University School of Medicine
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 through completion of follow-up (estimated to be 36 months)
Awards & highlights
Study Summary
This trial explores if a drug could be safe & effective for advanced skin cancer, after one prior systemic therapy.
Who is the study for?
This trial is for adults with advanced mycosis fungoides or Sézary syndrome who have tried at least one systemic therapy. They should be relatively healthy, able to perform daily activities, and have adequate organ function and blood counts. Pregnant women can't participate, and participants must use contraception.Check my eligibility
What is being tested?
The trial tests Tulmimetostat (CPI-0209) on patients with specific skin lymphomas to see if it's safe and effective after other treatments failed. It's given as a single agent, meaning no other drugs are combined in the treatment regimen.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver issues or allergic reactions. The exact side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of follow-up (estimated to be 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 36 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and grades of treatment-emergent adverse events (TEAE)
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAE)
Secondary outcome measures
Best overall response rate
Complete remission rate
Duration of response among responding patients
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort: Tulmimetostat (CPI-0209)Experimental Treatment1 Intervention
Daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will be the maximum-tolerated dose found during the dose de-escalation cohort.
Group II: Dose De-Escalation Cohort: Tulmimetostat (CPI-0209)Experimental Treatment1 Intervention
Daily CPI-0209 by mouth for days 1-28 of each 28-day cycle. Dose will depend on dose level assignment of 300 mg daily, 250 mg daily, or 200 mg daily.
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Who is running the clinical trial?
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,751 Total Patients Enrolled
Swim Across AmericaUNKNOWN
4 Previous Clinical Trials
155 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,665 Total Patients Enrolled
1 Trials studying Sezary Syndrome
54 Patients Enrolled for Sezary Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lymphoma in my central nervous system.I have been treated with an EZH2 inhibitor before.I had local radiation therapy at least 2 weeks ago.I am not on any immunosuppressive drugs except for steroids.I have had a solid organ transplant.I stopped using topical retinoids, nitrogen mustard, or imiquimod at least a week ago.I do not have severe stomach or bowel problems that could affect medication absorption.I have not had a heart attack or stroke in the last 3 months.I had cancer before, but it was treated over 2 years ago and I'm currently cancer-free.It's been over 4 weeks since my last cancer treatment, except for alemtuzumab which was over 16 weeks ago.I have severe GVHD needing strong medication.I do not have an active infection needing IV drugs within the last 14 days.I have confirmed mycosis fungoides or Sézary syndrome, stages IB to IVB.I have liver disease that is causing symptoms.I had low-dose skin radiation therapy at least 8 weeks ago.I have a serious heart condition.I have severe heart failure or heart muscle disease.My high blood pressure is not controlled despite taking two different medications.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.My white blood cell count is healthy without needing medication for 2 weeks.I haven't taken strong CYP3A affecting drugs or foods in the last 7 days.I am not on any other experimental drugs or systemic treatments for my condition.I haven't had major surgery in the last 4 weeks or am fully recovered from one.I had a stem cell transplant from a donor within the last 3 months.I have chronic hepatitis B or C but meet the specific testing criteria for safe treatment.My kidney function, measured by creatinine clearance, is sufficient.I agree to use effective birth control during and after the study as required.I have not had unstable chest pain in the last 3 months.I haven't taken certain cancer or skin treatment drugs in the last 2 weeks.My brain scans show no worsening after treatment for brain metastases.I have a history of serious heart rhythm problems.I have undergone at least one round of systemic therapy.I've been stable on certain skin creams or low-dose steroids for over 4 weeks.My blood counts and organ functions are within normal ranges.I am not on high-dose steroids or other strong immune system drugs.I do not have an active or chronic infection with HIV, hepatitis B, or hepatitis C.
Research Study Groups:
This trial has the following groups:- Group 1: Dose De-Escalation Cohort: Tulmimetostat (CPI-0209)
- Group 2: Dose Expansion Cohort: Tulmimetostat (CPI-0209)
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 any vacancies in this experiment that participants may apply for?
"According to clinicaltrials.gov, this research project is not enrolling new participants at present. It was originally published on the 30th of September 2023 and most recently revised on the 5th of July 2023. Nonetheless there are 1484 other trials that are actively looking for volunteers right now."
Answered by AI
What outcome is this clinical research attempting to ascertain?
"The primary objective of this trial, which will be evaluated over a period of 13 months starting from the beginning of treatment and lasting for 30 days after completion, is to measure the rate of patients who discontinued their medication due to adverse events. Secondary outcomes consist in assessing overall response rates according to Global Response Criteria for CTCL (Olsen et al., 2022), best overall response rates, and time taken by patients to reach maximum responses."
Answered by AI
Has Tulmimetostat (CPI-0209) been given the green light by the FDA for Dose De-Escalation Cohort?
"Our team at Power believes that the safety of Dose De-Escalation Cohort: Tulmimetostat (CPI-0209) merits a score of 1 due to its Phase 1 status, signifying only minimal data in regards to efficacy and safety."
Answered by AI
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