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2015-04-14
2018-01-31
2018-01-31
69
NCT02431260
Incyte Corporation
Incyte Corporation
INTERVENTIONAL
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
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).
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2015-04-27 | 2019-01-29 | 2019-05-17 |
2015-04-29 | 2019-05-17 | 2019-06-14 |
2015-04-30 | 2019-06-14 | 2019-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
N/A
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: INCB054329 Monotherapy | DRUG: INCB054329 Monotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of Participants With a Treatment-emergent Adverse Event (TEAE) | 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. | up to 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) Analysis of INCB054329 | 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. | Summary of steady-state PK parameters by dosing regimen at Day 15 |
| Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329 | 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. | Summary of steady-state PK parameters by dosing regimen at Day 15 |
| Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329 | 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. | Summary of steady-state PK parameters by dosing regimen at Day 15 |
| AUC0-t Analysis of INCB054329 | 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. | Summary of steady-state PK parameters by dosing regimen at Day 15 |
| Cl/F Analysis of INCB054329 | Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water. | Summary of steady-state PK parameters by dosing regimen at Day 15 |
| Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329 | 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. | Day 15 in all cohorts |
| Objective Response Rate (ORR) | 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). | Baseline through end of study, up to 6 months |
| Duration of Response (DOR) | Defined as the time from earliest date of disease response until earliest date of disease progression or death. | Baseline through end of study, up to 6 months |
| Progression Free Survival (PFS) | PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first | Baseline through end of study, up to 6 months |
| Overall Survival (OS) | OS is defined as the time from the date of randomization to the date of the participant's death. | Baseline through end of study, up to 6 months for participants in Part 2 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
