Fedratinib for Isocitrate Dehydrogenase Mutation

Phase-Based Progress Estimates
University of Chicago Medical Center, Chicago, ILIsocitrate Dehydrogenase Mutation+4 MoreFedratinib - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is testing the safety and effectiveness of combining three drugs to treat rare blood cancers.

Eligible Conditions
  • Isocitrate Dehydrogenase Mutation
  • IDH2 Gene Mutation
  • Myeloproliferative Neoplasms
  • Isocitrate Dehydrogenase 1 Mutation
  • Blood Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 24 months

12 months
1-Year Overall Survival
24 months
Maximum Tolerated Dose of Fedratinib Combined with Enasidenib in Participants Who Have IDH2 Mutations
Maximum Tolerated Dose of Fedratinib Combined with Ivosidenib in Participants Who Have IDH1 Mutations
Overall Response Rate (ORR)
Time to Response

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm B - Participants with IDH2 Mutations
1 of 2
Arm A - Participants with IDH1 Mutations
1 of 2

Experimental Treatment

50 Total Participants · 2 Treatment Groups

Primary Treatment: Fedratinib · No Placebo Group · Phase 1

Arm B - Participants with IDH2 MutationsExperimental Group · 2 Interventions: Enasidenib, Fedratinib · Intervention Types: Drug, Drug
Arm A - Participants with IDH1 MutationsExperimental Group · 2 Interventions: Ivosidenib, Fedratinib · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

University of ChicagoLead Sponsor
935 Previous Clinical Trials
754,084 Total Patients Enrolled
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
44 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with a specific type of blood cancer that has a mutation called IDH and has spread to an advanced stage. You are at least 18 years old and have a normal kidney and liver function. You have not had any major surgical procedures, radiation therapy, or participated in other clinical trials within the past 2 weeks. Female patients must have a negative pregnancy test and agree to use birth control. You understand and agree to sign an informed consent form.

Frequently Asked Questions

Has Fedratinib been given the go-ahead from the FDA?

"In the absence of substantial evidence regarding its safety and efficacy, Fedratinib received a score of 1." - Anonymous Online Contributor

Unverified Answer

To what ailment is Fedratinib most regularly prescribed?

"Fedratinib has been primarily utilized to treat high-risk IPSS patients. It is also used therapeutically for leukemia, myelocytic and acute primary myelofibrosis as well as idh1 mutation susceptibilities." - Anonymous Online Contributor

Unverified Answer

Is this trial setting a precedent for similar research?

"Research into Fedratinib began in 2013, and the first trial was conducted by Celgene. After 345 participants were studied, Phase 1 & 2 approval of the drug occurred and now there are 46 live trials for it across 255 cities around 45 nations." - Anonymous Online Contributor

Unverified Answer

How many participants are included in this research endeavor?

"Affirmative. Online records on clinicaltrials.gov verify that this study is presently recruiting individuals, beginning with its initial posting in October 2021 and most recently edited in November of the same year. Fifty participants are needed at only one site for enrollment." - Anonymous Online Contributor

Unverified Answer

Are there current opportunities for volunteers to participate in this research?

"As indicated by clinicaltrials.gov, this medical research is actively seeking participants. The study was first publicised on October 29th 2021 and has been amended as recently as November 12th 2021" - Anonymous Online Contributor

Unverified Answer

What other experiments have been conducted with Fedratinib?

"Currently, Fedratinib is the subject of 46 distinct clinical trials. 5 of these are in their final phase 3 stage and 1523 locations across the world offer this treatment to patients. The majority of trial sites for Fedratinib are located in Edmonton, Alberta." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.