Safety Study of INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Conditions
Metastatic Cancer - Metastatic Pancreatic Cancer
Conditions: official terms
Neoplasm Metastasis - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: INCB039110 Type: Drug
Name: Gemcitabine Type: Drug
Name: nab-paclitaxel Type: Drug
Name: filgrastim Type: Drug
Overall Status
Recruiting
Summary
Test the hypothesis that 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 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: This phase will explore the safety and clinical activity of the treatment regimen identified in Part 1 in subjects with advanced or metastatic pancreatic cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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)

- 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
Locations
Scottsdale, Arizona, United States
Status: Active, not recruiting
Fayetteville, Arkansas, United States
Status: Recruiting
Indianapolis, Indiana, United States
Status: Recruiting
Baltimore, Maryland, United States
Status: Active, not recruiting
Lake Success, New York, United States
Status: Recruiting
Philadelphia, Pennsylvania, United States
Status: Recruiting
Start Date
June 2013
Completion Date
June 2016
Sponsors
Incyte Corporation
Source
Incyte Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page