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Trial record 5 of 14 for:    cholangiocarcinoma | United States, North Carolina

Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT02924376
First received: October 4, 2016
Last updated: February 1, 2017
Last verified: February 2017
  Purpose
The purpose of this study is evaluate the efficacy of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocation who have failed at least 1 previous treatment.

Condition Intervention Phase
Cholangiocarcinoma
Drug: INCB054828
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Objective response rate (ORR) in subjects with FGFR2 translocations based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]
    ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.


Secondary Outcome Measures:
  • ORR in subjects with FGF/FGFR alterations other than FGFR2 translocations, all subjects with FGF/FGFR alterations, and subjects negative for FGF/FGFR alterations, based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months ]
    ORR defined as the proportion of subjects who achieved a complete response (disappearance of all target lesions) or a partial response (≥ 30% decrease in the sum of the longest diameters of target lesions) based on RECIST v1.1.

  • Progression-free survival based on RECIST v1.1 [ Time Frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 6 months. ]
    Progression-free survival defined as the time from the first day of taking study drug to death or disease progression by RECIST v1.1.

  • Safety and tolerability of INCB054828 as assessed by the frequency, duration, and severity of adverse events [ Time Frame: From screening through 30-35 days after end of treatment, up to 6 months. ]

Estimated Enrollment: 100
Study Start Date: October 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A INCB054828
INCB054828 in subjects with FGFR2 translocation
Drug: INCB054828
INCB054828 once daily
Experimental: Cohort B INCB054828
INCB054828 in subjects with other FGF/FGFR alterations
Drug: INCB054828
INCB054828 once daily
Experimental: Cohort C INCB054828
INCB054828 in subjects negative for FGF/FGFR alteration
Drug: INCB054828
INCB054828 once daily

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed cholangiocarcinoma.
  • Radiographically measurable or evaluable disease per RECIST v1.1.
  • Tumor assessment for FGF/FGFR gene alteration status completed through the central laboratory.
  • Documented disease progression after at least 1 line of prior systemic therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Life expectancy ≥ 12 weeks.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor.
  • History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications.
  • Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc, confirmed by ophthalmologic examination.
  • Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed.
  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: NCT02924376

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, Arizona
Recruiting
Tucson, Arizona, United States
United States, California
Recruiting
San Francisco, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Kansas
Recruiting
Westwood, Kansas, United States
United States, Montana
Recruiting
Billings, Montana, United States
United States, New Jersey
Recruiting
Morristown, New Jersey, United States
United States, North Carolina
Recruiting
Goldsboro, North Carolina, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Recruiting
Fort Worth, Texas, United States
Recruiting
Waco, Texas, United States
United States, Virginia
Recruiting
Fairfax, Virginia, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Ekaterine Asatiani, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02924376     History of Changes
Other Study ID Numbers: INCB 54828-202 
Study First Received: October 4, 2016
Last Updated: February 1, 2017

Keywords provided by Incyte Corporation:
Cholangiocarcinoma
fibroblast growth factor (FGF)
fibroblast growth factor receptor (FGFR)
FGF/FGFR alterations

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 17, 2017