This trial has been completed.

Conditions metastatic cancer, metastatic pancreatic cancer
Treatments itacitinib, gemcitabine, nab-paclitaxel, filgrastim
Phase phase 1/phase 2
Targets JAK, JAK1
Sponsor Incyte Corporation
Start date June 2013
End date February 2016
Trial size 55 participants
Trial identifier NCT01858883, INCB 39110-116


Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
itacitinib INCB039110
gemcitabine Gemzar®
nab-paclitaxel Abraxane®
filgrastim Neupogen®

Primary Outcomes

Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events
time frame: 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 (approximately 6 months).
Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered
time frame: Each cohort will be observed for a minimum of 28 days.

Secondary Outcomes

Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
time frame: Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
time frame: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2) - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 - Received no more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part 1) - Received no prior chemotherapy for advanced or metastatic disease (Part 2 and Part 2a) - Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months) - Ability to swallow and retain oral medication Exclusion Criteria: - Any known contraindications to the use of a required comedication (gemcitabine or nab-paclitaxel). - Evidence of uncontrolled brain metastases or history of uncontrolled seizures. - Ongoing radiation therapy and/or radiation therapy administered within 28 days of enrollment or ongoing radiotherapy-related toxicities. - Presence of ≥ Grade 2 neuropathy. - Inability to swallow food or any condition of the upper GI tract that precludes administration of oral medications. - Recent (≤ 3 months) history of partial or complete bowel obstruction. - Unwillingness to be transfused with blood components. - Known history of Hepatitis B or C infection or HIV infection

Additional Information

Official title Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Description Study Part 1: This is a dose optimization phase designed to find a tolerated regimen that includes identifying the MTD of itacitinib (INCB039110) (within a defined pharmacologic range) in combination with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors. Study Part 2 and Part 2A: This phase will explore the safety and tolerability of the MTD or PAD of itacitinib (INCB039110) when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by Incyte Corporation.