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Trial record 8 of 152 for:    cholangiocarcinoma | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02924376
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: INCB054828 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : October 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A INCB054828
INCB054828 in subjects with FGFR2 translocation with a documented fusion partner in central laboratory report
Drug: INCB054828
INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off therapy

Experimental: Cohort B INCB054828
INCB054828 in subjects with other FGF/FGFR alterations
Drug: INCB054828
INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off therapy

Experimental: Cohort C INCB054828
INCB054828 in subjects negative for FGF/FGFR alteration
Drug: INCB054828
INCB054828 once a day by mouth for 2 consecutive weeks and 1 week off therapy




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
  • 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 clinically significant corneal or retinal disorder 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924376


Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

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Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Luis Féliz Vinas, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02924376     History of Changes
Other Study ID Numbers: INCB 54828-202
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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