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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Lenograstim; Paclitaxel

Criteria

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