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

July 16, 2019 updated by: Incyte Corporation

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

Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • Arkansas
      • Fayetteville, Arkansas, United States
    • California
      • Beverly Hills, California, United States
    • Connecticut
      • Southington, Connecticut, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • New York
      • Lake Success, New York, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: itacitinib, gemcitabine, nab-paclitaxel, filgrastim
Drug: Gemcitabine
Other Names:
  • Gemzar®
Drug: filgrastim
Other Names:
  • Neupogen®
Drug: nab-paclitaxel
Other Names:
  • Abraxane®
Drug: itacitinib
Other Names:
  • INCB039110

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)
Time Frame: Baseline up to 6 months.
Baseline up to 6 months.
Clinical activity as measured by the greatest decrease in tumor burden compared to baseline.
Time Frame: Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).
Baseline and approximately every two cycles throughout the study until study completion or early termination (approximately 6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 16, 2013

First Posted (ESTIMATE)

May 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 16, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 39110-116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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