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Ann Arbor, Michigan 48109

  • Solid Tumors and Hematologic Malignancy

Purpose:

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).


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


Study is Available At:


Original ID:

INCB 54329-101


NCT ID:

NCT02431260


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054329 in Subjects With Advanced Malignancies


Overall Status:

Terminated


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Incyte Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

As of 31 JAN 2018, the study was terminated


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

69


Enrollment Type:

Actual


Overall Contact Information

Official Name:Fred Zheng, M.D.
Study Director
Incyte Corporation

Study Dates

Start Date:April 14, 2015
Completion Date:January 31, 2018
Completion Type:Actual
Primary Completion Date:January 31, 2018
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 17, 2019
First Received Date:April 27, 2015
First Results Date:January 29, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Participants With a Treatment-emergent Adverse Event (TEAE)
Time Frame:up to 30 days
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Maximum Plasma Concentration (Cmax) Analysis of INCB054329
Time Frame:Summary of steady-state PK parameters by dosing regimen at Day 15
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329
Time Frame:Summary of steady-state PK parameters by dosing regimen at Day 15
Safety Issues:False
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.
Outcome Type:Secondary Outcome
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
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:AUC0-t Analysis of INCB054329
Time Frame:Summary of steady-state PK parameters by dosing regimen at Day 15
Safety Issues:False
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.
Outcome Type:Secondary Outcome
Measure:Cl/F Analysis of INCB054329
Time Frame:Summary of steady-state PK parameters by dosing regimen at Day 15
Safety Issues:False
Description:Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.
Outcome Type:Secondary Outcome
Measure:Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329
Time Frame:Day 15 in all cohorts
Safety Issues:False
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 m
Outcome Type:Secondary Outcome
Measure:Objective Response Rate (ORR)
Time Frame:Baseline through end of study, up to 6 months
Safety Issues:False
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).
Outcome Type:Secondary Outcome
Measure:Duration of Response (DOR)
Time Frame:Baseline through end of study, up to 6 months
Safety Issues:False
Description:Defined as the time from earliest date of disease response until earliest date of disease progression or death.
Outcome Type:Secondary Outcome
Measure:Progression Free Survival (PFS)
Time Frame:Baseline through end of study, up to 6 months
Safety Issues:False
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
Outcome Type:Secondary Outcome
Measure:Overall Survival (OS)
Time Frame:Baseline through end of study, up to 6 months for participants in Part 2
Safety Issues:False
Description:OS is defined as the time from the date of randomization to the date of the participant's death.

Study Interventions

Intervention Type:Drug
Name: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
Arm Name:INCB054329 Monotherapy

Study Arms

Study Arm Type:Experimental
Arm Name:INCB054329 Monotherapy

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Incyte Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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