NCT02431260 · REGISTRY CONDITION SEARCH

An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2019-06-14

This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With a Treatment-emergent Adverse Event (TEAE)

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outcome · POSTED

Maximum Plasma Concentration (Cmax) Analysis of INCB054329

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outcome · POSTED

Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329

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outcome · POSTED

Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329

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outcome · POSTED

AUC0-t Analysis of INCB054329

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outcome · POSTED

Cl/F Analysis of INCB054329

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outcome · POSTED

Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Key Inclusion Criteria: * Confirmed diagnosis of advanced malignancy: * Treatment Group A (TGA): Part 1 and Part 2: Any advanced solid tumor or lymphoma; Part 3: Histologically confirmed disease in specific solid tumors and lymphomas * Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia \[AML\] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF) * Treatment Group C (TGC): Multiple myeloma * Progressed following at least 1 line of prior therapy and there is no further approved therapy available that has been demonstrated to prolong survival (including subjects who are intolerant to the approved therapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in Parts 1 and 2 dose escalation and titration, and 0, 1, 2 in Part 3 dose expansion Key Exclusion Criteria: * Inadequate hematopoietic, liver, endocrine or renal function * Receipt of anticancer medications or investigational drugs within the following interval before the first administration of study drug: * \< 6 weeks for mitomycin-C or nitrosoureas * \< 5 half-lives or 14 days, whichever is longer, for any investigational agent (for any indication) * \< 28 days for any antibodies or biological therapies * \< 5 half-lives for all other anticancer medications, or sponsor approval * Prior radiotherapy within 2 weeks prior to first dose of study drug * Untreated brain or central nervous system (CNS) metastases * Type 1 diabetes or uncontrolled Type 2 diabetes * Any sign of clinically significant bleeding
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: INCB054329 Monotherapy
label
INCB054329 Monotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
INCB054329 Monotherapy
description
Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
name
INCB054329 Monotherapy
type
DRUG

Study design

intervention Model

SEQUENTIAL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 69
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
measure
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
time Frame
up to 30 days

secondary Outcomes

description
Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
measure
Maximum Plasma Concentration (Cmax) Analysis of INCB054329
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
description
Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
measure
Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
description
Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.
measure
Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
description
AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). Study drug was administered with 240 mL of water.
measure
AUC0-t Analysis of INCB054329
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
description
Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
measure
Cl/F Analysis of INCB054329
time Frame
Summary of steady-state PK parameters by dosing regimen at Day 15
description
The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data. The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined. Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.
measure
Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
time Frame
Day 15 in all cohorts
description
Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).
measure
Objective Response Rate (ORR)
time Frame
Baseline through end of study, up to 6 months
description
Defined as the time from earliest date of disease response until earliest date of disease progression or death.
measure
Duration of Response (DOR)
time Frame
Baseline through end of study, up to 6 months
description
PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first
measure
Progression Free Survival (PFS)
time Frame
Baseline through end of study, up to 6 months
description
OS is defined as the time from the date of randomization to the date of the participant's death.
measure
Overall Survival (OS)
time Frame
Baseline through end of study, up to 6 months for participants in Part 2

Full study description

brief Summary: This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment groups also had an intra-patient dose titration (Part 2).

Source references

references

citation
Falchook G, Rosen S, LoRusso P, Watts J, Gupta S, Coombs CC, Talpaz M, Kurzrock R, Mita M, Cassaday R, Harb W, Peguero J, Smith DC, Piha-Paul SA, Szmulewitz R, Noel MS, Yeleswaram S, Liu P, Switzky J, Zhou G, Zheng F, Mehta A. Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies. Clin Cancer Res. 2020 Mar 15;26(6):1247-1257. doi: 10.1158/1078-0432.CCR-18-4071. Epub 2019 Sep 16.
pmid
31527168
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice