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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT01858883
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • itacitinib — DRUG
  • Gemcitabine — DRUG
  • nab-paclitaxel — DRUG
  • filgrastim — DRUG

Study Details

Test the hypothesis that itacitinib (INCB039110) can be administered safely in combination with gemcitabine and nab-paclitaxel in subjects with advanced or metastatic cancer.

Key Dates

Start date
Jun 30, 2013
Status verified
Jul 2019
Primary completion
Feb 29, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: itacitinib, gemcitabine, nab-paclitaxel, filgrastim

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). ]

Locations (8)

FacilityCityStateZIPSite coordinators
-ScottsdaleArizona--
-FayettevilleArkansas--
-Beverly HillsCalifornia--
-SouthingtonConnecticut--
-IndianapolisIndiana--
-BaltimoreMaryland--
-Lake SuccessNew York--
-PhiladelphiaPennsylvania--

Find similar trials in Scottsdale, AZ

By condition
Pancreatic cancer
By specialty
OncologyGI oncology

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