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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858883
First Posted: May 21, 2013
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Incyte Corporation
  Purpose
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 Intervention Phase
Metastatic Cancer Metastatic Pancreatic Cancer Drug: itacitinib Drug: Gemcitabine Drug: nab-paclitaxel Drug: filgrastim Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • 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). ]
  • 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. ]

Secondary Outcome Measures:
  • Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110) [ Time Frame: 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). ]

Enrollment: 55
Study Start Date: June 2013
Study Completion Date: March 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: itacitinib, gemcitabine, nab-paclitaxel, filgrastim Drug: itacitinib
Other Name: INCB039110
Drug: Gemcitabine
Other Name: Gemzar®
Drug: nab-paclitaxel
Other Name: Abraxane®
Drug: filgrastim
Other Name: Neupogen®

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858883


Locations
United States, Arizona
Scottsdale, Arizona, United States
United States, Arkansas
Fayetteville, Arkansas, United States
United States, California
Beverly Hills, California, United States
United States, Connecticut
Southington, Connecticut, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New York
Lake Success, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Albert Assad, M.D. Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01858883     History of Changes
Other Study ID Numbers: INCB 39110-116
First Submitted: May 14, 2013
First Posted: May 21, 2013
Last Update Posted: April 19, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Paclitaxel
Gemcitabine
Albumin-Bound Paclitaxel
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic