NCT02719574 · OUTCOME

Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)

Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation · Source last updated 2026-06-29

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: Full Range
Time frame: Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

What was measured

TTR is the time in months between the first dose of study drug and documentation of the first overall response for participants who achieve a PR or better. This analysis was performed only on participants who have achieved PR or better as a best overall response.

Analysis population: 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 PR or better as a best overall response.

Groups in this outcome

Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)

Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.

Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)

Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.

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 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)	1
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)	4

Reported measurements

Source class 1

Values in Months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)	3.30	Not reported	3.3	3.3	Not reported
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)	1.50	Not reported	1.0	13.0	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.3
upper Limit
3.3
value
3.30
group Id
OG001
lower Limit
1.0
upper Limit
13.0
value
1.50

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
4
units
Participants

description

dispersion Type

Full Range

groups

description
Participants with R/R AML that is naïve to prior hypomethylating therapy and IDH1 inhibitor therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
id
OG000
title
Phase 2: Cohort 4; FT-2102 + Azacitidine (Combination Therapy)
description
Participants with R/R AML/MDS that have inadequately responded to or have progressed on prior hypo-methylating therapy received combination therapy of azacitidine 75 mg/m\^2 + FT-2102 150 mg BID in continuous 28-day cycles.
id
OG001
title
Phase 2: Cohort 5; FT-2102 + Azacitidine (Combination Therapy)

param Type

MEDIAN

population Description

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 PR or better as a best overall response.

reporting Status

POSTED

time Frame

Phase 2: Time from first dose of study drug until documentation of the first overall response (up to 82 months)

title

Phase 2, Cohort 4 and Cohort 5: Time to Response (TTR) for Myelodysplastic Syndrome (MDS)

type

SECONDARY

unit Of Measure

Months

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

Preserved source evidence · Not medical advice