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

NCT01858883 | Completed Phase 1

• 1 other identifier: INCB 39110-116
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

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.

Conditions

Solid Tumors; Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (2)

• Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent itacitinib (INCB039110)

  Baseline up to 6 months.

• 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).

Study Arms (1)

itacitinib, gemcitabine, nab-paclitaxel, filgrastim

EXPERIMENTAL

Drug: itacitinib; Drug: Gemcitabine; Drug: nab-paclitaxel; Drug: filgrastim

Interventions

itacitinib DRUG

Also known as: INCB039110

itacitinib, gemcitabine, nab-paclitaxel, filgrastim

Gemcitabine DRUG

Also known as: Gemzar®

itacitinib, gemcitabine, nab-paclitaxel, filgrastim

nab-paclitaxel DRUG

Also known as: Abraxane®

itacitinib, gemcitabine, nab-paclitaxel, filgrastim

filgrastim DRUG

Also known as: Neupogen®

itacitinib, gemcitabine, nab-paclitaxel, filgrastim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (8)

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Fayetteville, Arkansas, United States

Location

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Southington, Connecticut, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Lake Success, New York, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Related Publications (1)

• 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.

  PMID: 30115734 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

itacitinib; INCB039110; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Filgrastim

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Albert Assad, M.D.

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 21, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (8)