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

• Register: EUCTR
• Last refreshed on: 13 March 2017
• Main ID: EUCTR2016-002596-10-ES
• Date of registration: 28/02/2017
• Prospective Registration: No
• Primary sponsor: Incyte Corporation
• Public 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
• Scientific 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
• Date of first enrolment: 27/02/2017
• Target sample size: 46
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002596-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, France, Germany, Italy, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Trials Information
• Affiliation: Incyte Corporation

• Name: Clinical Trials Information
• Affiliation: Incyte Corporation

Key inclusion & exclusion criteria

Inclusion criteria:
• Men and women, aged 18 or older.
• 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.
• Only subjects who are not candidates for stem cell transplantation, or have relapsed after stem cell transplantation and delayed lymphocyte infusion and who have progressed and are not candidates for other disease-modifying therapies are eligible for the study. All relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment).
• Life expectancy = 12 weeks.
• ECOG performance status 0 to 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to FGFR1 activation

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Code: INCB054828
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: INCB054828
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 2-4.5

Primary Outcome(s)

Primary end point(s): The primary endpoint of this study is to determine the overall clinical benefit rate by achieving 1 of the following: complete response (CR), partial response (PR), complete hematologic response (CHR), cytogenetic response, marrow response, or clinical benefit.

Timepoint(s) of evaluation of this end point: Bone marrow biopsies or aspirates will be obtained before randomization and then every 3 cycles starting from Cycle 2 Day 1. After the first 12 months of treatment, a bone marrow biopsy or aspirate will be obtained every 6 cycles for subjects who have not yet achieved complete cytogenic response (CCyR) or every 12 cycles if the subject has a confirmed CCyR until Month 24. Following Month 24, a bone marrow biopsy or aspirate will be obtained every 12 months until disease progression or end of treatment.

Secondary Objective: The secondary objective is to evaluate the safety of INCB054828 in subjects with myeloid/lymphoid neoplasms with FGFR1 rearrangement.

Main Objective: The primary objective of this study is to evaluate the efficacy of INCB054828 in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1 rearrangement.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 3 cycles starting from Cycle 2 Day 1. After the first 12 months of treatment, a bone marrow biopsy or aspirate will be obtained every 6 cycles for subjects who have not yet achieved complete cytogenic response (CCyR) or every 12 cycles if the subject has a confirmed CCyR until Month 24. Following Month 24, a bone marrow biopsy or aspirate will be obtained every 12 months until disease progression or end of treatment

Secondary end point(s): • Duration of response/benefit.
• Progression-free survival.
• Overall survival.
• Safety and tolerability, as assessed by evaluating the frequency, duration, and severity of adverse events; through review of findings of physical examinations, changes in vital signs, and electrocardiograms (ECGs); and through clinical laboratory blood and urine sample evaluations.

Secondary ID(s)

INCB54828-203

Source(s) of Monetary Support

Incyte Corporation