Trial · NCT03684811
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
NCT03684811, Phase 1, Phase 2, Completed, Forma Therapeutics, Inc.; results first posted 2023-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation. Trials, record NCT03684811. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03684811
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
- NCT number
- NCT03684811
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- Forma Therapeutics, Inc.
- Conditions
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma, Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
- Interventions
- FT-2102, Azacitidine, Nivolumab, Gemcitabine and Cisplatin
- First posted
- 2018-09-26
- Last updated
- 2023-11-18
- Results first posted
- 2023-01-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Dose Limiting Toxicity (DLT) | Day 1-28 | DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting \<72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for \>7 days. |
| Primary | Overall Response Rate (ORR) | While on treatment | ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2 |
| Secondary | Peak Plasma Concentration (Cmax) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Peak Plasma Concentration (Cmax) was summarized for Cycle 1 and Cycle 2. |
| Secondary | Time of Peak Plasma Concentration (Tmax) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Time of peak plasma concentration (Tmax) was summarized for Cycle 1 and Cycle 2. |
| Secondary | Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Time for half of the drug to be absent in blood stream following dose (T 1/2) |
| Secondary | Apparent Clearance (CL/F) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Rate at which drug is removed from the blood stream (CL/F). |
| Secondary | Rate of Drug Distribution Within the Blood Stream (Vd/F) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | Rate of drug distribution within the blood stream (Vd/F) |
| Secondary | Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF) | CSF sample for drug concentration was collected at Day 1 of Cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average. | Olutasidenib concentration within CSF (Glioma Cohorts 1-A and 1-B only). Due to sparse data, analysis was not conducted by timepoint. |
| Secondary | Progression-Free Survival (PFS) | From time of entry on study through progression, up to 24 weeks, on average | Progression-Free Survival from time of entry on study. Progression-free survival (PFS) is defined as the time from the first dose to disease progression as determined by applicable disease criteria or death due to any cause, whichever was sooner. Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Dose Limiting Toxicity (DLT) | Day 1-28 | All patients in the Safety Lead-in Period who either experienced a DLT during Cycle 1 or completed at least 75% of the prescribed Cycle 1 dose. The Safety-Lead-in Period will employ a traditional 3+3 design, whereby 3 patients with any of the solid tumors (Cohorts 2a-5) and 3 patients with gliomas (Cohort 1a) are treated with FT-2102 150 mg BID and monitored for DLTs during the first cycle of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Response Rate (ORR) | While on treatment | The Response-Evaluable Analysis Set is defined as all patients with measurable disease at baseline are included in the Safety Analysis Set and had at least 1 post-baseline response assessment or discontinued the treatment phase due to disease progression (including death caused by disease progression) within 8 weeks (+2-week window) of the first dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve (AUC) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients from Stage 1 who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). | h*ng/mL | MEAN |
| SECONDARY | Peak Plasma Concentration (Cmax) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients from Stage 1 who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). | ng / mL | MEAN |
| SECONDARY | Time of Peak Plasma Concentration (Tmax) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). | hours | MEDIAN |
| SECONDARY | Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). Results were not estimable for this outcome measure because of the limited sampling interval post Day 1. | ng / mL | MEAN |
| SECONDARY | Apparent Clearance (CL/F) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). Results were not estimable for this outcome measure because of the limited sampling interval post Day 1. | units | GEOMETRIC_MEAN |
| SECONDARY | Rate of Drug Distribution Within the Blood Stream (Vd/F) | Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose). | The PK analysis set is defined as patients who have received at least one dose of FT-2102 and for whom it is possible to calculate at least one primary PK parameter (e.g. Cmax, AUC). Results were not estimable for this outcome measure because of the limited sampling interval post Day 1. | units | NUMBER |
| SECONDARY | Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF) | CSF sample for drug concentration was collected at Day 1 of Cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average. | Glioma patients who had a CSF sample obtained while on study treatment were analyzed. CSF samples were not collected for cohorts 2-5, per protocol. | ng/mL | MEAN |
| SECONDARY | Progression-Free Survival (PFS) | From time of entry on study through progression, up to 24 weeks, on average | The Response-Evaluable Analysis Set is defined as all patients with measurable disease at baseline are included in the Safety Analysis Set and had at least 1 post-baseline response assessment or discontinued the treatment phase due to disease progression (including death caused by disease progression) within 8 weeks (+2-week window) of the first dose of study treatment. | weeks | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group87
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Dose Limiting Toxicity (DLT) | Cohort 1A | 0 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) | Cohort 1B | 2 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) | Cohort 3A | 0 | Participants | ||
| Number of Participants With a Dose Limiting Toxicity (DLT) | Cohort 5A | 1 | Participants | ||
| Overall Response Rate (ORR) | Cohort 1A | 2 | Participants | ||
| Overall Response Rate (ORR) | Cohort 1B | 0 | Participants | ||
| Overall Response Rate (ORR) | Cohort 2A | 1 | Participants | ||
| Overall Response Rate (ORR) | Cohort 3A | 0 | Participants | ||
| Overall Response Rate (ORR) | Cohort 4A | 0 | Participants | ||
| Overall Response Rate (ORR) | Cohort 5A | 0 | Participants |
1 to 10 of 87Source ClinicalTrials.gov
See all 87 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1A | 26 | |
| Overall Study | STARTED | Cohort 1B | 6 | |
| Overall Study | STARTED | Cohort 2A | 8 | |
| Overall Study | STARTED | Cohort 2B | 0 | |
| Overall Study | STARTED | Cohort 3A | 23 | |
| Overall Study | STARTED | Cohort 3B | 0 | |
| Overall Study | STARTED | Cohort 4A | 24 | |
| Overall Study | STARTED | Cohort 4B | 0 | |
| Overall Study | STARTED | Cohort 5A | 6 | |
| Overall Study | COMPLETED | Cohort 1A | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events894
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 | Tachycardia | Cardiac disorders | Cohort 1A | 0 | 26 | |
| other | Tachycardia | Cardiac disorders | Cohort 1B | 0 | 6 | |
| other | Tachycardia | Cardiac disorders | Cohort 2A | 0 | 8 | |
| other | Tachycardia | Cardiac disorders | Cohort 3A | 2 | 23 | |
| other | Tachycardia | Cardiac disorders | Cohort 4A | 0 | 24 | |
| other | Tachycardia | Cardiac disorders | Cohort 5A | 0 | 6 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 1A | 0 | 26 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 1B | 0 | 6 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 2A | 1 | 8 | |
| other | Sinus bradycardia | Cardiac disorders | Cohort 3A | 0 | 23 |
1 to 10 of 894Source ClinicalTrials.gov
See all 894 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1A | 2 | 26 |
| Total, all-cause mortality | Cohort 1B | 0 | 6 |
| Total, all-cause mortality | Cohort 2A | 0 | 8 |
| Total, all-cause mortality | Cohort 3A | 2 | 23 |
| Total, all-cause mortality | Cohort 4A | 4 | 24 |
| Total, all-cause mortality | Cohort 5A | 1 | 6 |
| Total, other adverse events | Cohort 1A | 26 | 26 |
| Total, other adverse events | Cohort 1B | 6 | 6 |
| Total, other adverse events | Cohort 2A | 8 | 8 |
| Total, other adverse events | Cohort 3A | 21 | 23 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41611702 | DERIVED |
Source PubMed
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.
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