Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
NCT ID: NCT01858883
Last Updated: 2019-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
55 participants
INTERVENTIONAL
2013-06-30
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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itacitinib, gemcitabine, nab-paclitaxel, filgrastim
itacitinib
Gemcitabine
nab-paclitaxel
filgrastim
Interventions
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itacitinib
Gemcitabine
nab-paclitaxel
filgrastim
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Albert Assad, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Scottsdale, Arizona, United States
Fayetteville, Arkansas, United States
Beverly Hills, California, United States
Southington, Connecticut, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Lake Success, New York, United States
Philadelphia, Pennsylvania, United States
Countries
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References
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Beatty GL, Shahda S, Beck T, Uppal N, Cohen SJ, Donehower R, Gabayan AE, Assad A, Switzky J, Zhen H, Von Hoff DD. A Phase Ib/II Study of the JAK1 Inhibitor, Itacitinib, plus nab-Paclitaxel and Gemcitabine in Advanced Solid Tumors. Oncologist. 2019 Jan;24(1):14-e10. doi: 10.1634/theoncologist.2017-0665. Epub 2018 Aug 16.
Other Identifiers
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INCB 39110-116
Identifier Type: -
Identifier Source: org_study_id
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