NCT01915498 · OUTCOME

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From time of first dose up to the end of Cycle 1; 28 days

What was measured

Toxicity severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT was defined as: • Non-hematologic toxicities: CTCAE ≥ Grade 3 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 toxicities: Prolonged myelosuppression, defined as persistence of ≥ Grade 3 neutropenia or thrombocytopenia (by NCI CTCAE v4.03), leukemia-specific criteria, i.e., marrow cellularity \<5% on Day 28 or later from the start of study drug without evidence of leukemia) at least 42 days after the initiation of Cycle 1 therapy. Leukemia-specific grading was used for cytopenias (based on percentage decrease from Baseline: 50 to 75% = Grade 3, \>75% = Grade 4)

Analysis population: All participants who took at least one dose of study drug in the dose escalation phase and either had a DLT during Cycle 1, regardless of the amount of study drug exposure, or had no DLT and completed at least 75% of their planned Cycle 1 doses, and were considered to have had enough safety data to conclude that a DLT did not occur during Cycle 1.

Groups in this outcome

Phase 1 Dose Escalation: Enasidenib 30 mg BID

Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 50 mg BID

Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 75 mg BID

Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 100 mg BID

Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 150 mg BID

Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 50 mg QD

Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 75 mg QD

Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 100 mg QD

Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 150 mg QD

Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 200 mg QD

Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 300 mg QD

Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 450 mg QD

Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Phase 1 Dose Escalation: Enasidenib 650 mg QD

Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Phase 1 Dose Escalation: Enasidenib 30 mg BID	4
Phase 1 Dose Escalation: Enasidenib 50 mg BID	5
Phase 1 Dose Escalation: Enasidenib 75 mg BID	5
Phase 1 Dose Escalation: Enasidenib 100 mg BID	7
Phase 1 Dose Escalation: Enasidenib 150 mg BID	4
Phase 1 Dose Escalation: Enasidenib 50 mg QD	0
Phase 1 Dose Escalation: Enasidenib 75 mg QD	0
Phase 1 Dose Escalation: Enasidenib 100 mg QD	5
Phase 1 Dose Escalation: Enasidenib 150 mg QD	6
Phase 1 Dose Escalation: Enasidenib 200 mg QD	6
Phase 1 Dose Escalation: Enasidenib 300 mg QD	4
Phase 1 Dose Escalation: Enasidenib 450 mg QD	5
Phase 1 Dose Escalation: Enasidenib 650 mg QD	5

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1 Dose Escalation: Enasidenib 30 mg BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 50 mg BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 75 mg BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 100 mg BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 150 mg BID	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 50 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 75 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 100 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 150 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 200 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 300 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 450 mg QD	0	Not reported	Not reported	Not reported	Not reported
Phase 1 Dose Escalation: Enasidenib 650 mg QD	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
group Id
OG010
value
0
group Id
OG011
value
0

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
7
group Id
OG004
value
4
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
5
group Id
OG008
value
6
group Id
OG009
value
6
group Id
OG010
value
4
group Id
OG011
value
5
units
Participants

description

groups

description
Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG000
title
Phase 1 Dose Escalation: Enasidenib 30 mg BID
description
Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG001
title
Phase 1 Dose Escalation: Enasidenib 50 mg BID
description
Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG002
title
Phase 1 Dose Escalation: Enasidenib 75 mg BID
description
Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG003
title
Phase 1 Dose Escalation: Enasidenib 100 mg BID
description
Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG004
title
Phase 1 Dose Escalation: Enasidenib 150 mg BID
description
Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG005
title
Phase 1 Dose Escalation: Enasidenib 50 mg QD
description
Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG006
title
Phase 1 Dose Escalation: Enasidenib 75 mg QD
description
Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG007
title
Phase 1 Dose Escalation: Enasidenib 100 mg QD
description
Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG008
title
Phase 1 Dose Escalation: Enasidenib 150 mg QD
description
Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG009
title
Phase 1 Dose Escalation: Enasidenib 200 mg QD
description
Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG010
title
Phase 1 Dose Escalation: Enasidenib 300 mg QD
description
Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
id
OG011
title
Phase 1 Dose Escalation: Enasidenib 450 mg QD

param Type

COUNT_OF_PARTICIPANTS

population Description

All participants who took at least one dose of study drug in the dose escalation phase and either had a DLT during Cycle 1, regardless of the amount of study drug exposure, or had no DLT and completed at least 75% of their planned Cycle 1 doses, and were considered to have had enough safety data to conclude that a DLT did not occur during Cycle 1.

reporting Status

POSTED

time Frame

From time of first dose up to the end of Cycle 1; 28 days

title

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice