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Keep this study
Lead
Incyte Corporation
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
