Trial · NCT02719574
Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
NCT02719574, Phase 1, Phase 2, Completed, Forma Therapeutics, Inc.; results first posted 2025-06-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation. Trials, record NCT02719574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02719574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation
- NCT number
- NCT02719574
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 336 participants, actual
- Lead sponsor
- Forma Therapeutics, Inc.
- Conditions
- Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome
- Interventions
- FT-2102 (olutasidenib), Azacitidine, Cytarabine
- First posted
- 2016-03-25
- Last updated
- 2026-06-29
- Results first posted
- 2025-06-26
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months) | A TEAE was defined as an adverse event (AE) that emerges during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. Number of participants with TEAEs and SAEs is reported. Safety analysis set (SAS) included all the participants who have received at least one dose of study drug (FT-2102, azacitidine, or cytarabine). |
| Primary | Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) | Number of participants with change from baseline in clinically significant abnormal laboratory values for hematology, chemistry and coagulation with Grade \<1 to 4 is reported. National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 toxicity grade used to determine severity of AE. Grade 1: mild;asymptomatic/mild symptoms; Grade 2: moderate; minimal; Grade 3: severe/medically significant; Grade 4: life-threatening consequences, Grade 5: death. |
| Primary | Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) | Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) | Number of participants with change from baseline in clinically significant abnormal ECG parameter (QTcF) is reported. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. |
| Primary | Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\], Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts less than (\<) 5 percent (%) (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, absolute neutrophil count (ANC) greater than or equal to (\>=) 1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is defined as CR with unde-tectable IDH1m minimal residual disease (MRD) and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L). |
| Primary | Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | Percentage of participants with CR plus CRh (CR, Molecular CR \[CRm\]), Cytogenetic CR \[CRc\], CRh) is re-ported. CR is defined as bone marrow blasts \<5 % (in aspirate with spicules and 200 nucleated cells), no blasts with auer rods, no extramedullary disease, ANC \>=1000/μL, platelet count \>=100,000/μL and transfusion independ-ence. CRc is defined as CR with no residual cytogenetic abnormalities. CRm is de-fined as CR with undetectable IDH1m MRD and CRh is defined as bone marrow blasts and partial recovery of peripheral blood counts (platelet count \>50 × 10\^9/L and ANC \> 0.5 × 10\^9/L). |
| Primary | Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | Percentage of participants with complete remission (CR) is reported. CR is defined as bone marrow blast ≤ 5% myeloblasts with normal maturation of all cell lines, peripheral blood: Hgb ≥11 grams per deciliter (g/dL), platelets ≥ 100 × 10\^9/L, neutrophils ≥ 1.0 × 10\^9/L and blasts 0%. |
| Primary | Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate | Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months) | RFS is defined as the time between the date of first dose until relapse or death from any cause, whichever occurs first. RFS is calculated for all participants in Phase 2 Cohort 2. 4-Month RFS rate is defined as the percentage of participants in Phase 2 Cohort 2 who have not relapsed or died on or before their 4-month response evaluation. |
| Secondary | Phase 1: Area Under the Curve (AUClast) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | Area under the plasma concentration-time curve from zero time until the last measurable concentration is presented. |
| Secondary | Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | Maximum plasma concentration (Cmax) for FT-2102 is presented. |
| Secondary | Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | Time to reach the maximum plasma concentration (Tmax) is presented. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: From start of drug administration (Day 1) up to 28 days after last dose of study drug (up to 82 months) | SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in statistical analysis plan (SAP). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) | SAS analyzed. Since 150 mg BID has been established as MTD, the analysis was directed towards emphasizing findings that are most relevant for determining a safe and effective treatment strategy. Accordingly, data for the other dose levels (100 mg QD, 150 mg QD, and 300 mg QD) were combined as prespecified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) | Phase 1: From Baseline up to 28 days after last dose of study drug (up to 82 months) | SAS. Here, N=Number of participants with available data. Since 150mg BID has been established as MTD, analysis was directed towards emphasizing findings that are most relevant for determining safe and effective treatment strategy. Accordingly, data for other dose levels (100mg QD, 150mg QD, and 300mg QD) were combined as prespecified in SAP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2, Cohort 1: Percentage of Participants With Complete Remission (CR) Plus Complete Remission With Partial Hematological Recovery (CRh) for Acute Myeloid Leukemia Assessed by Investigator Based on International Working Group (IWG) Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | Efficacy evaluable analysis set included all participants in Phase 2, Cohort 1 with confirmed IDH1-R132 who have received the first dose of FT-2102 180 days or more prior to the analysis cutoff date. This outcome measure is applicable only for Cohort 1. | Percentage of participants | NUMBER |
| PRIMARY | Phase 2, Cohort 3, 4, 5, 6, 7, 8: Percentage of Participants With CR Plus CRh for Acute Myeloid Leukemia Assessed by Investigator Based on IWG Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 3, 4, 5, 6, 7 and 8. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Phase 2, Cohort 4 and 5: Percentage of Participants With CR for MDS Assessed by IWG Response Criteria | Phase 2: up to 3 weeks post last dose of study drug or until the introduction of new anticancer therapy, whichever is earlier (up to 82 months) | FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 4 and 5. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Phase 2, Cohort 2: Four-month Relapse Free Survival (RFS) Rate | Phase 2: From the date of first dose until relapse or death from any cause, whichever occurs first (up to 4 months) | FAS included all the participants who were enrolled in the study and have received at least one dose of FT-2102. This outcome measure is applicable for Cohort 2. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1: Area Under the Curve (AUClast) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | The pharmacokinetic (PK) analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints. | Hour*nanograms per millilitre (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Maximum Plasma Concentration (Cmax) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints. | Nanograms per millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 1: Time to Maximum Plasma Concentration (Tmax) for FT-2102 | Phase 1: Cycle 1 Day 1 and Cycle 2 Day 1 (Cycle length= 28 days) | The PK analysis set included those participants for whom it was possible to calculate at least 1 primary PK parameter and who had no major protocol deviations thought to influence the absorption, distribution, metabolism, and excretion of the FT-2102. Here, number anaylzed (n) = participants with available data for specific timepoints. | hour | MEDIAN |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group1,968
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: FT-2102 (Single Agent) | TEAEs | 16 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: Total FT-2102 (Single Agent) | TEAEs | 31 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: FT-2102 + Azacitidine (Combination Therapy) | TEAEs | 39 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | TEAEs | 46 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: FT-2102 (Single Agent) | SAEs | 10 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: Total FT-2102 (Single Agent) | SAEs | 23 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: FT-2102 + Azacitidine (Combination Therapy) | SAEs | 30 | Participants | |
| Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | SAEs | 36 | Participants | |
| Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Phase 1: FT-2102 (Single Agent) | Hematology: Hemoglobin; Increase(Grade <1) | 15 | Participants | |
| Phase 1: Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values | Phase 1: Total FT-2102 (Single Agent) | Hematology: Hemoglobin; Increase(Grade <1) | 30 | Participants |
1 to 10 of 1,968Source ClinicalTrials.gov
See all 1,968 results by groupParticipant flow153
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 100mg QD (Single Agent; Dose Escalation) | 3 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg QD (Single Agent; Dose Escalation) | 8 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg BID (Single Agent; Dose Escalation) | 7 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 300mg QD (Single Agent; Dose Escalation) | 4 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg QD+Azacitidine (Combination Therapy; Dose Escalation) | 7 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Escalation) | 8 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg BID (Single Agent; Dose Expansion) | 0 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg BID+Azacitidine (Combination Therapy; Dose Expansion) | 0 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 1: FT-2102 150mg BID+ Cytarabine (Combination Therapy; Dose Expansion) | 0 | |
| Phase 1 (Dose Escalation) | STARTED | Phase 2: Cohort 1; FT-2102 (Single Agent) | 0 |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 participant flowAdverse events7,969
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: FT-2102 (Single Agent) | 1 | 16 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Total FT-2102 (Single Agent) | 5 | 31 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 3 | 39 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 4 | 46 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 1: Overall | 9 | 78 | 10 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Cohort 1; FT-2102 (Single Agent) | 2 | 153 | 3 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Cohort 2; FT-2102 (Single Agent) | 1 | 18 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Cohort 3; FT-2102 (Single Agent) | 0 | 5 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 0 | 20 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 1 | 21 | 1 |
1 to 10 of 7,969Source ClinicalTrials.gov
See all 7,969 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: FT-2102 (Single Agent) | 4 | 16 |
| Total, all-cause mortality | Phase 1: Total FT-2102 (Single Agent) | 11 | 31 |
| Total, all-cause mortality | Phase 1: FT-2102 + Azacitidine (Combination Therapy) | 9 | 39 |
| Total, all-cause mortality | Phase 1: Total FT-2102; FT-2102 + Azacitidine (Combination Therapy) | 10 | 46 |
| Total, all-cause mortality | Phase 1: Overall | 21 | 78 |
| Total, all-cause mortality | Phase 2: Cohort 1; FT-2102 (Single Agent) | 50 | 153 |
| Total, all-cause mortality | Phase 2: Cohort 2; FT-2102 (Single Agent) | 0 | 18 |
| Total, all-cause mortality | Phase 2: Cohort 3; FT-2102 (Single Agent) | 2 | 5 |
| Total, all-cause mortality | Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy) | 3 | 20 |
| Total, all-cause mortality | Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy) | 6 | 21 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02719574
GET https://conductscience.org/api/trials/v1/NCT02719574/registered?page=2