← Back to Search

IDH1 Inhibitor

FT-2102 +/− Azacitidine/Cytarabine for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
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 blood samples for pk analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, FT-2102 (olutasidenib), as a single agent or in combination with azacitidine or cytarabine, for treating patients with various states of AML/MDS.

Who is the study for?
This trial is for adults with AML or high-risk MDS who have an IDH1 mutation and whose disease hasn't responded to standard treatments, or they can't receive them. Participants should be in good physical condition with proper kidney and liver function but cannot join if they have severe heart issues, uncontrolled infections, or urgent CNS metastases needing immediate treatment.Check my eligibility
What is being tested?
The study tests FT-2102 (olutasidenib) alone or combined with azacitidine or cytarabine in patients. It has two parts: dose escalation to find the safe amount of drugs and dose expansion to see how well these treatments work on different AML/MDS conditions.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, gastrointestinal symptoms like nausea and vomiting, blood count changes leading to increased infection risk, fatigue, liver enzyme alterations indicating potential liver damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples for pk analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples for pk analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles following the first 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gonadorelin
Complete Response (CR and CRh) Rate of FT-2102 (olutasidenib) single-agent or in combination with Azacitidine in patients with AML/MDS [Phase 2 Cohorts 1, 3-8]
Doses recommended for future studies [Phase 1]
+2 more
Secondary outcome measures
Additional measures of antileukemic or antimyelodysplastic activity as determined by CRi, MLFS, Marrow CR, PR, Overall Response (OR), and Stable Disease (SD) of FT-2102 (olutasidenib) alone or in combination with azacitidine [Phase 2]
Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2]
Duration of Response (DOR) [Phase 2]
+11 more

Trial Design

11Treatment groups
Experimental Treatment
Group I: PH2 Cohort 8 FT-2102 (olutasidenib)+AzacitidineExperimental Treatment2 Interventions
Treatment naïve AML who are candidates for azacitidine first line treatment
Group II: PH2 Cohort 7 FT-2102 (olutasidenib) Single AgentExperimental Treatment1 Intervention
Treatment naïve AML for whom standard treatments are contraindicated
Group III: PH2 Cohort 6 FT-2102 (olutasidenib)+AzacitidineExperimental Treatment2 Interventions
R/R AML/MDS that have been previously treated with single-agent FT-2102 as their last therapy prior to study enrollment
Group IV: PH2 Cohort 5 FT-2102 (olutasidenib)+AzacitidineExperimental Treatment2 Interventions
R/R AML/MDS that have inadequately responded to or have progressed on prior hypomethylating therapy
Group V: PH2 Cohort 4 FT-2102 (olutasidenib)+AzacitidineExperimental Treatment2 Interventions
R/R AML/MDS that are naïve to prior hypomethylating therapy and IDH1 inhibitor therapy
Group VI: PH2 Cohort 3 FT-2102 (olutasidenib) Single AgentExperimental Treatment1 Intervention
R/R AML/MDS, previously treated with FT-2102
Group VII: PH2 Cohort 2 FT-2102 (olutasidenib) Single AgentExperimental Treatment1 Intervention
AML in morphologic complete remission or complete remission with incomplete blood count recovery (CR/CRi) after prior therapy with residual IDH1-R132 mutation
Group VIII: PH2 Cohort 1 FT-2102 (olutasidenib) Single AgentExperimental Treatment1 Intervention
Relapsed or Refractory (R/R) AML
Group IX: PH1 Esc. and Exp. FT-2102 (olutasidenib)+CytarabineExperimental Treatment2 Interventions
Group X: PH1 Esc. and Exp. FT-2102 (olutasidenib)+AzacitidineExperimental Treatment2 Interventions
Group XI: PH1 Dose Escalation & Expansion FT-2102 (olutasidenib)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FT-2102 (olutasidenib)
2016
Completed Phase 2
~340
Azacitidine
2012
Completed Phase 3
~1440
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,478 Total Patients Enrolled
Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
913 Total Patients Enrolled
Emma BarrettStudy DirectorForma Therapeutics, Inc.
1 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

FT-2102 (olutasidenib) (IDH1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02719574 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: PH2 Cohort 1 FT-2102 (olutasidenib) Single Agent, PH1 Dose Escalation & Expansion FT-2102 (olutasidenib), PH1 Esc. and Exp. FT-2102 (olutasidenib)+Cytarabine, PH2 Cohort 2 FT-2102 (olutasidenib) Single Agent, PH2 Cohort 3 FT-2102 (olutasidenib) Single Agent, PH2 Cohort 4 FT-2102 (olutasidenib)+Azacitidine, PH2 Cohort 5 FT-2102 (olutasidenib)+Azacitidine, PH2 Cohort 6 FT-2102 (olutasidenib)+Azacitidine, PH2 Cohort 7 FT-2102 (olutasidenib) Single Agent, PH2 Cohort 8 FT-2102 (olutasidenib)+Azacitidine, PH1 Esc. and Exp. FT-2102 (olutasidenib)+Azacitidine
Acute Myeloid Leukemia Clinical Trial 2023: FT-2102 (olutasidenib) Highlights & Side Effects. Trial Name: NCT02719574 — Phase 1 & 2
FT-2102 (olutasidenib) (IDH1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02719574 — Phase 1 & 2

Frequently Asked Questions

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

Are people currently being signed up to participate in this clinical trial?

"According to the listing on clinicaltrials.gov, this study is not currently looking for new participants. The trial was originally posted on 4/1/2016 and the most recent update was on 3/2/2022. There are 2118 other trials that have open recruitment at this time."

Answered by AI

Is this particular clinical trial taking place at more than one hospital in America?

"There are 19 active clinical trial sites for this study, located in Nashville, New york, Portland, and other cities."

Answered by AI

Are there any limitations as to how many people can join this trial?

"Unfortunately, this study is no longer looking for participants. However, there are presently 1714 trials actively looking for patients with leukemia and myeloid and 404 studies for FT-2102 (olutasidenib) that may be of interest."

Answered by AI

What are the precedent studies for FT-2102 (olutasidenib)?

"There are currently 404 ongoing trials researching the efficacy of FT-2102 (olutasidenib), with 87 of them being in Phase 3. New york, New York has a significant presence for these studies, however there are 14257 locations across the world conducting research on FT-2102 (olutasidenib)."

Answered by AI

Which condition does FT-2102 (olutasidenib) target?

"FT-2102 (olutasidenib) is the standard of care for meningeal leukemia. Additionally, FT-2102 has shown efficacy in treating other blood disorders like refractory anemias and blast phase chronic myelocytic leukemia."

Answered by AI
~38 spots leftby Mar 2025