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A Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Incyte Corporation
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT03011372
First received: January 4, 2017
Last updated: August 15, 2017
Last verified: August 2017
  Purpose
The purpose of this study is to evaluate the efficacy and safety of INCB054828 in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

Condition Intervention Phase
Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement Drug: INCB054828 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Overall clinical benefit rate based on response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
    Clinical benefit rate defined as the proportion of subjects who achieved a complete response (CR), partial response (PR), complete hematologic response (CHR), cytogenetic response, marrow response, or clinical benefit.


Secondary Outcome Measures:
  • Duration of response/benefit [ Time Frame: Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. ]
    Defined as the time from the date when the subject first achieves response/benefit until the date of the first documented disease progression.

  • Progression-free survival (PFS) [ Time Frame: From the date of first study drug dose until the date of disease progression or until death due to any cause, whichever is earlier, assessed up to approximately 24 months. ]
    PFS is defined as the time from the first date of taking study drug until the date of disease progression, as measured by response criteria for myeloid/lymphoid neoplasms with FGFR1 rearrangement, or until death due to any cause, whichever is earlier.

  • Overall survival [ Time Frame: From date of first study drug dose until death due to any cause, assessed up to approximately 24 months. ]
    Overall survival is defined as the time from the first day of taking study drug until death due to any cause. Subjects without death observed at the time of the analysis will be censored at last date known to be alive.

  • Safety and tolerability as assessed by frequency, duration, and severity of adverse events [ Time Frame: From baseline through 30-35 days after end of treatment, up to 7 months per individual subject ]
    A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).


Estimated Enrollment: 46
Actual Study Start Date: December 26, 2016
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCB054828 Drug: INCB054828
INCB054828 at the protocol-defined once-daily dose.

  Eligibility

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

Inclusion Criteria:

  • Documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
  • Subjects must be relapsed/refractory. Prior stem cell transplantation is allowed.
  • Life expectancy ≥ 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

  • Prior receipt of a selective FGFR inhibitor.
  • History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except 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, and keratoconjunctivitis, as confirmed by ophthalmologic examination.
  • Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
  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: NCT03011372

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

  Show 24 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Ekaterine Asatiani, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03011372     History of Changes
Other Study ID Numbers: INCB 54828-203
Study First Received: January 4, 2017
Last Updated: August 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Myeloid neoplasm
fibroblast growth factor receptor inhibitor
FGFR1 rearrangement
8p11
eosinophilia
eosinophilic syndrome
Lymphoid neoplasm

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 21, 2017