Pancreatic Cancer, Solid Tumors
Conditions
Brief summary
Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.
Detailed 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.
Interventions
DRUGitacitinib
DRUGGemcitabine
DRUGnab-paclitaxel
DRUGfilgrastim
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | Each cohort will be observed for a minimum of 28 days. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110) | Baseline up to 6 months. |
| Clinical activity as measured by the greatest decrease in tumor burden compared to baseline. | Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months). |
Countries
United States
Outcome results
None listed