NCT03072043 · OUTCOME

Phase 1b: Maximum Tolerated Dose (MTD)

Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms · Source last updated 2022-01-24

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

Measure: NUMBER
Unit: mg/day
Interval / dispersion: Not reported
Time frame: Up to 12 months

What was measured

Maximum Tolerated Dose, defined as the dose level below which dose limiting toxicity (DLT) is manifested in ≥33% of the patients or at dose level 3 if DLT is manifested in \<33% of the patients.

Groups in this outcome

Phase 1b Dose Escalation

Participants will receive intravenous infusions of APR-246 as a lead-in phase on days -14 to -11 starting at Dose Level 1 prior to starting cycle #1 of combination therapy with azacitidine. Combination therapy will consist of APR-246 on days 1-4 and azacitidine on days 4-10 (or days 4-5 and 8-12) of a 28 day cycle. APR-246: Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD). Azacitidine: Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\^2.

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 1b Dose Escalation	12

Reported measurements

Source class 1

Values in mg/day · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1b Dose Escalation	4500	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4500

denoms

counts
group Id
OG000
value
12
units
Participants

description

Maximum Tolerated Dose, defined as the dose level below which dose limiting toxicity (DLT) is manifested in ≥33% of the patients or at dose level 3 if DLT is manifested in \<33% of the patients.

groups

description
Participants will receive intravenous infusions of APR-246 as a lead-in phase on days -14 to -11 starting at Dose Level 1 prior to starting cycle #1 of combination therapy with azacitidine. Combination therapy will consist of APR-246 on days 1-4 and azacitidine on days 4-10 (or days 4-5 and 8-12) of a 28 day cycle. APR-246: Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD). Azacitidine: Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\^2.
id
OG000
title
Phase 1b Dose Escalation

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 12 months

title

Phase 1b: Maximum Tolerated Dose (MTD)

type

PRIMARY

unit Of Measure

mg/day

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice