Trial · NCT02273739
Study of Orally Administered Enasidenib (AG-221) in Adults With Advanced Solid Tumors, Including Glioma, or Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation
NCT02273739, Phase 1, Phase 2, Completed, Celgene; results first posted 2021-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Orally Administered Enasidenib (AG-221) in Adults With Advanced Solid Tumors, Including Glioma, or Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation. Trials, record NCT02273739. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02273739
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Orally Administered Enasidenib (AG-221) in Adults With Advanced Solid Tumors, Including Glioma, or Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation
- NCT number
- NCT02273739
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Solid Tumor, Glioma, Angioimmunoblastic T-cell Lymphoma, Intrahepatic Cholangiocarcinoma, Chondrosarcoma
- Interventions
- Enasidenib
- First posted
- 2014-10-24
- Last updated
- 2021-02-23
- Other registries' IDs
- eudract:2014-003424-47
- Results first posted
- 2021-02-23
- Limitations and caveats
The study was to be conducted in 2 parts: a dose-escalation and an expansion phase. Enrollment was closed after entry into Cohort 4 to focus resources on the development of other pipeline IDH inhibitors in other tumors; there were no safety concerns.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug to 28 days after last dose; median (minimum, maximum) duration of exposure was 66 (8, 197) days across all cohorts. | Treatment-emergent adverse events included any adverse events (AEs) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of the study drug. Severity was graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 or according to the following scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Fatal, death related to AE. A serious AE is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required or prolonged existing inpatient hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event. Relationship to study drug administration was determined by the investigator as not related, possibly related, or probably related; all AEs classified as possibly or probably related were considered treatment-related. |
| Primary | Number of Participants With Dose-limiting Toxicities | Cycle 1 (28 days) | Toxicities were graded and documented according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. A dose-limiting toxicity (DLT) was defined as an event considered related to enasidenib and meeting 1 of the following criteria: Non-hematologic: \- All clinically significant non-hematologic toxicities CTCAE ≥ Grade 3, considered not related to underlying disease or intercurrent illness, with the exception of ≥ Grade 3 blood bilirubin increases in participants with a uridine diphosphate-glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) mutation. In participants with a UGT1A1 mutation, blood bilirubin increases of \> 5 × upper limit of normal (ULN) were considered a DLT. Hematologic: \- Drug-related, prolonged myelosuppression of ≥ Grade 4 neutropenia or thrombocytopenia lasting beyond Day 28 of Cycle 1 unless related to bone marrow involvement by AITL. |
| Primary | Eastern Cooperative Oncology Group (ECOG) Performance Status at Each Visit | Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and at end of treatment | ECOG performance status is used by doctors and researchers to assess how a subjects disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. * 0 = Fully active (most favorable activity); * 1 = Restricted activity but ambulatory; * 2 = Ambulatory but unable to carry out work activities; * 3 = Limited self-care; * 4 = Completely disabled, no self-care (least favorable activity). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for assessment of enasidenib pharmacokinetics (PK). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Enasidenib After a Single Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for assessment of enasidenib pharmacokinetics (PK). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. |
| Secondary | Area Under the Plasma Concentration Time Curve From Time Zero to 10 Hours Postdose (AUC0-10) of Enasidenib After a Single Oral Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, and 10 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for assessment of enasidenib pharmacokinetics (PK). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule. |
| Secondary | Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours Postdose (AUC0-72) of Enasidenib After a Single Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3) for assessment of enasidenib pharmacokinetics (PK). Plasma enasidenib was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 72 hours post-dose (AUC0-72) was calculated using the linear trapezoidal rule. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3 pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. |
| Secondary | Time of Maximum Plasma Concentration (Tmax) of Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time 0 to 10 Hours Postdose (AUC0-10) for Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, and 10 hours post-dose. | The first 3 to 5 participants enrolled in each cohort in the dose escalation phase received a single dose of enasidenib three days prior to starting the 28-day dosing regimen (Day -3). AGI-16903 is a primary metabolite of enasidenib. Plasma AGI-16903 was measured using validated liquid chromatography-mass spectrometry methods (LC-MS/MS). The lower limit of quantification (LLOQ) in plasma was 1.00 ng/mL. Area under the plasma concentration-time curve from time 0 to 10 hours post-dose (AUC0-10) was calculated using the linear trapezoidal rule. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug to 28 days after last dose; median (minimum, maximum) duration of exposure was 66 (8, 197) days across all cohorts. | All participants who were enrolled and received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose-limiting Toxicities | Cycle 1 (28 days) | All enrolled and treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Eastern Cooperative Oncology Group (ECOG) Performance Status at Each Visit | Baseline, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and at end of treatment | Enrolled participants with available data at each time point | score on a scale | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax) of Enasidenib After a Single Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration Time Curve From Time Zero to 10 Hours Postdose (AUC0-10) of Enasidenib After a Single Oral Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, and 10 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration Time Curve From Time Zero to 72 Hours Postdose (AUC0-72) of Enasidenib After a Single Dose on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3 pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax) of Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, 10, 24, 48, and 72 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters | hours | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time 0 to 10 Hours Postdose (AUC0-10) for Metabolite AGI-16903 After a Single Dose of Enasidenib on Day -3 | Day -3, pre-dose and at 30 minutes and 1, 2, 3, 4, 6, 8, and 10 hours post-dose. | Participants who received 1 dose of enasidenib on Day -3 with sufficient data to determine PK parameters. | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group186
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 Treatment-emergent Adverse Events (TEAEs) | Enasidenib 100 mg | ≥ 1 treatment-emergent adverse event (TEAE) | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 200 mg | ≥ 1 treatment-emergent adverse event (TEAE) | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 400 mg | ≥ 1 treatment-emergent adverse event (TEAE) | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 650 mg | ≥ 1 treatment-emergent adverse event (TEAE) | 7 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 100 mg | ≥ 1 treatment-related TEAE | 3 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 200 mg | ≥ 1 treatment-related TEAE | 4 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 400 mg | ≥ 1 treatment-related TEAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 650 mg | ≥ 1 treatment-related TEAE | 5 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 100 mg | ≥ 1 Grade 3/4 TEAE | 2 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Enasidenib 200 mg | ≥ 1 Grade 3/4 TEAE | 3 | Participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enasidenib 100 mg | 3 | |
| Overall Study | STARTED | Enasidenib 200 mg | 4 | |
| Overall Study | STARTED | Enasidenib 400 mg | 7 | |
| Overall Study | STARTED | Enasidenib 650 mg | 7 | |
| Overall Study | COMPLETED | Enasidenib 100 mg | 0 | |
| Overall Study | COMPLETED | Enasidenib 200 mg | 0 | |
| Overall Study | COMPLETED | Enasidenib 400 mg | 0 | |
| Overall Study | COMPLETED | Enasidenib 650 mg | 0 | |
| Overall Study | NOT COMPLETED | Enasidenib 100 mg | 3 | |
| Overall Study | NOT COMPLETED | Enasidenib 200 mg | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events652
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 | Anaemia | Blood and lymphatic system disorders | Enasidenib 100 mg | 1 | 3 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Enasidenib 200 mg | 1 | 4 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Enasidenib 400 mg | 3 | 7 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Enasidenib 650 mg | 1 | 7 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Enasidenib 100 mg | 0 | 3 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Enasidenib 200 mg | 0 | 4 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Enasidenib 400 mg | 2 | 7 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Enasidenib 650 mg | 0 | 7 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Enasidenib 100 mg | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Enasidenib 200 mg | 0 | 4 | 0 |
1 to 10 of 652Source ClinicalTrials.gov
See all 652 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enasidenib 100 mg | 1 | 3 |
| Total, all-cause mortality | Enasidenib 200 mg | 0 | 4 |
| Total, all-cause mortality | Enasidenib 400 mg | 1 | 7 |
| Total, all-cause mortality | Enasidenib 650 mg | 2 | 7 |
| Total, other adverse events | Enasidenib 100 mg | 3 | 3 |
| Total, other adverse events | Enasidenib 200 mg | 4 | 4 |
| Total, other adverse events | Enasidenib 400 mg | 6 | 7 |
| Total, other adverse events | Enasidenib 650 mg | 7 | 7 |
| Total, serious adverse events | Enasidenib 100 mg | 2 | 3 |
| Total, serious adverse events | Enasidenib 200 mg | 2 | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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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Read this trial from software.
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