Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumors, Pancreatic Cancer

In brief

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

Key facts

Study ID

NCT01858883

Run by

Incyte Corporation

People needed

55

Starts

2013-06-01

Expected to finish

2016-03-01

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Southington, Connecticut, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Lake Success, New York, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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