← Back to Search

DNA Methyltransferase Inhibitor

Tomivosertib for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Shira N Dinner
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients age >= 18 years
Patients must provide written, signed, and dated informed consent prior to study registration. Patient must have the ability to understand and the willingness to sign a written informed consent document. The patient must be willing and able to comply with the protocol for the duration of the study. No study-specific screening procedures may be performed until written consent has been obtained
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial will test a combination of drugs to treat AML, potentially killing more cancer cells.

Who is the study for?
Adults aged 18+ with newly diagnosed AML unsuitable for intensive chemotherapy due to age (75+), poor physical status, or severe heart/lung/liver conditions. Participants must not be pregnant/nursing and agree to use contraception. Those with controlled HIV/HBV/HCV are eligible.Check my eligibility
What is being tested?
The trial is testing Tomivosertib's optimal dose in treating AML. It starts at 100mg daily taken orally with meals, adjusting based on safety/effectiveness. Patients will take the drug continuously over a 28-day cycle alongside biospecimen collection for analysis.See study design
What are the potential side effects?
Potential side effects of Tomivosertib may include typical reactions seen with oral medications such as digestive issues, possible allergic reactions similar to other drugs in its class, and any general side effects that could arise from taking a new medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I understand the study, am willing to follow its rules, and have signed the consent form.
Select...
My AML has come back or didn't respond to treatment.
Select...
My hepatitis B virus is undetectable with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the dose of maximum pharmacologic activity (MPA) of tomivosertib
Secondary outcome measures
Complete remission rate (CRR)
Duration of response (DOR)
Frequency of adverse events
+5 more
Other outcome measures
Assess the steady-state pharmacokinetics of tomivosertib
Correlate MCL1 expression before and after treatment with treatment response.
Correlate eIF4E phosphorylation before and after cycle 1 treatment with treatment response.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tomivosertib)Experimental Treatment2 Interventions
Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,638 Previous Clinical Trials
40,929,804 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,581 Previous Clinical Trials
916,824 Total Patients Enrolled
EFFECTOR Therapeutics, Inc.UNKNOWN

Media Library

Azacitidine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05744739 — Phase 1
Acute Myeloid Leukemia Research Study Groups: Treatment (tomivosertib)
Acute Myeloid Leukemia Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT05744739 — Phase 1
Azacitidine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05744739 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities available to join this experiment at present?

"The clinicaltrials.gov registry reveals that this medical test is not actively recruiting participants, as the trial was initially posted on April 23rd 2023 and recently updated on February 16th 2023. Nonetheless, there are presently 1536 trials with open enrollment for potential patients to consider."

Answered by AI

What risks accompany the application of tomivosertib, azacitidine and venetoclax for treatment?

"According to our assessment at Power, the safety of Treatment (tomivosertib, azacitidine, venetoclax) was rated a 1 since it is still in its initial trial phase with limited evidence suggesting efficacy and safe use."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
2023. "Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05744739.
~10 spots leftby Apr 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top