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

Sponsor
Incyte Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01858883
Collaborator
(none)
55
Enrollment
8
Locations
1
Arm
33
Duration (Months)
6.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 with doses of gemcitabine and nab-paclitaxel that have established safety and tolerability in subjects with advanced or metastatic solid tumors.

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Official Title: A Phase 1B/2 Study of the Safety and Tolerability of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: itacitinib, gemcitabine, nab-paclitaxel, filgrastim

Drug: itacitinib
Other Names:
  • INCB039110

    • Drug: Gemcitabine
    Other Names:
  • Gemzar®

    • Drug: nab-paclitaxel
    Other Names:
  • Abraxane®

    • Drug: filgrastim
    Other Names:
  • Neupogen®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of combination therapy study treatment itacitinib (INCB039110) plus nab-paclitaxel and gemcitabine as measured by the number of participants with adverse events [Baseline and weekly for Cycle 1 and then Day 1, Week 8 and Week 15 for all subsequent cycles until the End of Treatment visit (approximately 6 months).]

    2. Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for itacitinib (INCB039110) in the treatment regimens administered [Each cohort will be observed for a minimum of 28 days.]

    Secondary Outcome Measures

    1. Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110) [Baseline up to 6 months.]

    2. Clinical activity as measured by the greatest decrease in tumor burden compared to baseline. [Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scottsdale Arizona United States
    2 Fayetteville Arkansas United States
    3 Beverly Hills California United States
    4 Southington Connecticut United States
    5 Indianapolis Indiana United States
    6 Baltimore Maryland United States
    7 Lake Success New York United States
    8 Philadelphia Pennsylvania United States

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Albert Assad, M.D., Incyte Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT01858883
    Other Study ID Numbers:
    • INCB 39110-116
    First Posted:
    May 21, 2013
    Last Update Posted:
    Jul 18, 2019
    Last Verified:
    Jul 1, 2019
    Additional relevant MeSH terms:
    Gemcitabine
    Paclitaxel

    Study Results

    No Results Posted as of Jul 18, 2019