- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2013-09
2014-08
2014-08
5
NCT01929941
Incyte Corporation
Incyte Corporation
INTERVENTIONAL
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
This is an open-label study of INCB047986 given to two distinct groups of patients (Group 1 and Group 2) with advanced malignancies. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of INCB047986 and to determine the maximum tolerated dose of INCB047986 in combination with gemcitabine and nab paclitaxel in a select group of patients with solid tumors. Each patient group will participate in a phase of the study which is divided into two parts. The patient groups will be enrolled in a sequential manner starting with Patient Group 1. Patient Group 1 Group 1 will be comprised of patients with advanced malignancies who will receive INCB047986 as monotherapy. Part 1: Dose Escalation Phase - This phase will evaluate the safety, tolerability and pharmacokinetics (PK) of INCB047986 when given as described to patients with advanced malignancies. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of INCB047986 and/or other dose(s) that are tolerated doses and produce a substantial pharmacologic effect. These doses will be used in Part 2 of the study. Part 2: Expansion Phase - This phase will further explore the safety, tolerability, PK, and preliminary clinical activity of INCB047986 using the doses identified in Part 1. Group 2 Group 2 will be in subjects with advanced or metastatic pancreatic cancer, breast cancer or urothelial cancer. Part 1: Dose Optimization Phase - This phase will identify the MTD of INCB047986 in combination with gemcitabine and nab-paclitaxel in patients with advanced or metastatic solid tumors. Specifically, these will be patients with pancreatic adenocarcinoma (first or second line), triple-negative breast cancer (second line) or urothelial cancer (second line). Part 2: Expansion Phase - This phase will explore the safety, tolerability, PK, biomarkers, and preliminary clinical activity of the dose regimen(s) identified in Part 1. Patients enrolled in this phase will be limited to those with advanced or metastatic pancreatic cancer.
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 |
|---|---|---|
2013-08-22 | N/A | 2018-01-15 |
2013-08-27 | N/A | 2018-01-17 |
2013-08-28 | N/A | 2018-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group 1 INCB047986 | DRUG: INCB047986
|
| EXPERIMENTAL: Group 2 Experimental: INCB047986, gemcitabine, nab-paclitaxel | DRUG: INCB047986
DRUG: Gemcitabine
DRUG: nab-paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adverse events that are defined as dose limiting toxicities occurring in the first 21 days of treatment in Group 1 and the first 28 days of treatment in Group 2. | Approximately 21 days (Group 1); Approximately 28 days (Group 2) | |
| Safety and tolerability of INCB047986 monotherapy and in combination with gemcitabine and nab-paclitaxel as assessed by summary of clinical laboratory assessments, Electrocardiogram (ECG), and Adverse Events (AEs). | Group 1: Baseline and weekly for Cycle 1 and then Day 1 for all subsequent cycles until the End of Treatment visit. Group 2: Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit. | Group 1 and Group 2: up to 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor response rates will be derived from investigator assessment of response in subjects with measurable disease | Approximately 6 months | |
| Plasma concentrations will be used to estimate peak plasma concentration (cmax) and area under the plasma concentration curve (AUC) | Day 15 of treatment at a given dose | |
| Duration of Response (DOR) and Progression Free Survival (PFS) in subjects with measureable disease | Approximately 6 months | |
| Plasma concentration of biomarkers and cytokines before and during treatment | Approximately 6 months | |
| Change in body weight | Approximately 6 months | |
| Change in Eastern Cooperative Oncology Group (ECOG) status from baseline to each visit where the variable is measured | Approximately 6 months |
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
No publications available
