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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

May 14, 2013
March 3, 2016
June 2013
February 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • 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). ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01858883 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma concentration of tumor specific biomarkers and cytokines before and during treatment. [ 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 ]
Not Provided
Not Provided
 
Safety Study of 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 INCB039110 in Combination With Gemcitabine and Nab-Paclitaxel in Subjects With Advanced Solid Tumors
Test the hypothesis that 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 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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Cancer
  • Metastatic Pancreatic Cancer
  • Drug: INCB039110
  • Drug: Gemcitabine
    Other Name: Gemzar®
  • Drug: nab-paclitaxel
    Other Name: Abraxane®
  • Drug: filgrastim
    Other Name: Neupogen®
Experimental: INCB039110, gemcitabine, nab-paclitaxel, filgrastim
Interventions:
  • Drug: INCB039110
  • 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.
 
Active, not recruiting
53
June 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
Both
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
March 2016

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