Status:
COMPLETED
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT01858883
Start Date
June 1 2013
End Date
March 1 2016
Last Update
July 18 2019
Active Locations (8)
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1
Scottsdale, Arizona, United States
2
Fayetteville, Arkansas, United States
3
Beverly Hills, California, United States
4
Southington, Connecticut, United States