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Completed

NCT Number: NCT01858883

Safety Study 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.

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Key information

Conditions

Solid Tumors Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Scottsdale, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Itacitinib

Drug

Other names: INCB039110

Gemcitabine

Drug

Other names: Gemzar®

Nab-paclitaxel

Drug

Other names: Abraxane®

Filgrastim

Drug

Other names: Neupogen®

Primary outcomes

  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

    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).

  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

    Time frame: Each cohort will be observed for a minimum of 28 days.

Secondary outcomes

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

    Time frame: Baseline up to 6 months.

  2. 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).

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 21, 2013
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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