Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02431260
NCT02431260
Terminated
Phase 1

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

Incyte Corporation12 sites in 1 country69 target enrollmentStarted: April 14, 2015Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSolid Tumors and Hematologic Malignancy
InterventionsINCB054329 Monotherapy
DrugsINCB054329 Monotherapy

Overview

Phase
Phase 1
Status
Terminated
Enrollment
69
Locations
12
Primary Endpoint
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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).

Study Design

Study Type
Interventional
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Arms & Interventions

INCB054329 Monotherapy

Experimental

Intervention: INCB054329 Monotherapy (Drug)

Outcomes

Primary Outcomes

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

Time Frame: up to 30 days

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.

Secondary Outcomes

  • Maximum Plasma Concentration (Cmax) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
  • Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
  • Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
  • AUC0-t Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
  • Cl/F Analysis of INCB054329(Summary of steady-state PK parameters by dosing regimen at Day 15)
  • Objective Response Rate (ORR)(Baseline through end of study, up to 6 months)
  • Progression Free Survival (PFS)(Baseline through end of study, up to 6 months)
  • Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329(Day 15 in all cohorts)
  • Duration of Response (DOR)(Baseline through end of study, up to 6 months)
  • Overall Survival (OS)(Baseline through end of study, up to 6 months for participants in Part 2)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (12)

Loading locations...

Similar Trials

Terminated
Phase 1
An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced MalignanciesSolid TumorsAdvanced MalignanciesMetastatic Cancer
NCT02265510Incyte Corporation83
Terminated
Phase 1
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced MalignanciesSolid Tumors and Hematologic Malignancy
NCT02712905Incyte Corporation116
Completed
Phase 1
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)B-Cell Malignancies
NCT02018861Incyte Corporation88
Completed
Phase 1
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors PatientsAdvanced/Metastatic Solid Tumors
NCT04501276Adagene Inc72
Terminated
Phase 1
Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced MalignanciesSolid Tumors
NCT02711137Incyte Corporation137