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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01858883
First received: May 14, 2013
Last updated: March 3, 2016
Last verified: March 2016
  Purpose
Test the hypothesis that 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: INCB039110
Drug: Gemcitabine
Drug: nab-paclitaxel
Drug: filgrastim
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Official Title: A Phase 1B/2 Study of the Safety and Tolerability of 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 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). ] [ Designated as safety issue: Yes ]
  • Identify the Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD) within a defined dose range for INCB039110 in the treatment regimens administered [ Time Frame: Each cohort will be observed for a minimum of 28 days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of gemcitabine and paclitaxel administered with or without concurrent INCB039110 [ Time Frame: Baseline up to 6 months. ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB039110, gemcitabine, nab-paclitaxel, filgrastim Drug: 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 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 INCB039110 when administered in combination with gemcitabine and nab-paclitaxel in subjects with untreated advanced or metastatic pancreatic cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: May 14, 2013
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016