Description:
The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828)
in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1
rearrangement.
Title
- Brief Title: A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
- Official Title: A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
Clinical Trial IDs
- ORG STUDY ID:
INCB 54828-203
- NCT ID:
NCT03011372
Conditions
- MPN (Myeloproliferative Neoplasms)
Interventions
| Drug | Synonyms | Arms |
|---|
| Pemigatinib | INCB054828 | Pemigatinib |
Purpose
The purpose of this study is to evaluate the efficacy and safety of pemigatinib (INCB054828)
in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (FGFR) 1
rearrangement.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Pemigatinib | Experimental | | |
Eligibility 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.
- Eligible subjects must:
- Have relapsed after stem cell transplantation or after other disease modifying
therapy, OR
- Not be current candidates for stem cell transplantation or other disease
modifying therapies.
- Note: 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.
- 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | The proportion of participants who achieve Complete Response (CR) 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. |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | The proportion of subjects who achieve response, defined as a best response of CR or PR, as determined by investigator assessment according to the response criteria |
| Time Frame: | Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. |
| Safety Issue: | |
| Description: | |
| Measure: | The proportion of subjects who achieve a complete cytogenetic response (CCyR) as assessed by local analysis and investigator evaluation |
| Time Frame: | Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. |
| Safety Issue: | |
| Description: | |
| Measure: | The proportion of subjects who achieve a partial cytogenetic response (PCyR) as assessed by local analysis and investigator evaluation |
| Time Frame: | Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of CR, defined as the time from first assessment of CR to the earlier of disease progression or death due to any cause |
| Time Frame: | Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response, defined as the time from first assessment of CR or PR to the earlier of disease progression or death due to any cause |
| Time Frame: | Assessed at protocol-defined timepoints through end of study, up to approximately 24 months. |
| Safety Issue: | |
| Description: | |
| Measure: | 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. |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Overall survival |
| Time Frame: | From date of first study drug dose until death due to any cause, assessed up to approximately 24 months. |
| Safety Issue: | |
| Description: | 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. |
| Measure: | 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 |
| Safety Issue: | |
| Description: | 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). |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Incyte Corporation |
Trial Keywords
- Myeloid neoplasm
- fibroblast growth factor receptor inhibitor
- FGFR1 rearrangement
- 8p11
- eosinophilia
- eosinophilic syndrome
- Lymphoid neoplasm
Last Updated
December 19, 2020
