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

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ClinicalTrials.gov Identifier: NCT01858883
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):

May 14, 2013
May 21, 2013
April 19, 2017
June 2013
February 2016   (Final data collection date for primary outcome measure)
  • 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. ]
  • Safety and tolerability of the treatment regimen 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) within a defined dose range for INCB039110 in the combination regimen. [ Time Frame: Each cohort will be observed for a minimum of 28 days. ]
Complete list of historical versions of study NCT01858883 on ClinicalTrials.gov Archive Site
  • 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). ]
  • Plasma concentration of tumor specific biomarkers and cytokines before and during treatment. [ 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). ]
Not Provided
Not Provided
 
Safety Study of Itacitinib (INCB039110) in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
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 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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Metastatic Cancer
  • Metastatic Pancreatic Cancer
  • Drug: itacitinib
    Other Name: INCB039110
  • Drug: Gemcitabine
    Other Name: Gemzar®
  • Drug: nab-paclitaxel
    Other Name: Abraxane®
  • Drug: filgrastim
    Other Name: Neupogen®
Experimental: itacitinib, gemcitabine, nab-paclitaxel, filgrastim
Interventions:
  • Drug: itacitinib
  • Drug: Gemcitabine
  • Drug: nab-paclitaxel
  • Drug: filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
March 2016
February 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01858883
INCB 39110-116
No
Not Provided
Not Provided
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Albert Assad, M.D. Incyte Corporation
Incyte Corporation
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP