An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT01929941|
Recruitment Status : Terminated (Business decision.)
First Posted : August 28, 2013
Last Update Posted : January 17, 2018
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Hodgkin's Lymphoma NHL (Non-Hodgkin Lymphoma) Pancreatic Cancer Breast Cancer UC (Ureter and Urethera) Advanced Cancer Metastatic Cancer||Drug: INCB047986 Drug: Gemcitabine Drug: nab-paclitaxel||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB047986 in Subjects With Advanced Malignancies|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
|Experimental: Group 1 INCB047986||
Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria
|Experimental: Group 2 Experimental: INCB047986, gemcitabine, nab-paclitaxel||
INCB047986 tablets administered orally at the protocol specified dose and frequency
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency
Other Name: Gemzar®
nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency
Other Name: Abraxane®
- 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. [ Time Frame: 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). [ Time Frame: Group 1 and Group 2: up to 6 months ]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.
- Tumor response rates will be derived from investigator assessment of response in subjects with measurable disease [ Time Frame: Approximately 6 months ]
- Plasma concentrations will be used to estimate peak plasma concentration (cmax) and area under the plasma concentration curve (AUC) [ Time Frame: Day 15 of treatment at a given dose ]
- Duration of Response (DOR) and Progression Free Survival (PFS) in subjects with measureable disease [ Time Frame: Approximately 6 months ]
- Plasma concentration of biomarkers and cytokines before and during treatment [ Time Frame: Approximately 6 months ]
- Change in body weight [ Time Frame: Approximately 6 months ]
- Change in Eastern Cooperative Oncology Group (ECOG) status from baseline to each visit where the variable is measured [ Time Frame: Approximately 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929941
|United States, Georgia|
|Atlanta, Georgia, United States|
|United States, Tennessee|
|Nashville, Tennessee, United States|
|United States, Texas|
|Dallas, Texas, United States|
|Study Director:||William Williams, M.D.||Incyte Corporation|