A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203)
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|ClinicalTrials.gov Identifier: NCT03011372|
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : October 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|MPN (Myeloproliferative Neoplasms)||Drug: Pemigatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||December 26, 2016|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
Participants enrolled under Protocol Amendment 5 dated 17th May 2018 will receive the drug once a day by mouth continuously.
Other Name: INCB054828
- 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.
- 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).
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): NCT03011372
|Contact: Incyte Corporation Call Center||1.855.463.3463|
|Contact: Incyte Corporation Call Center (ex-US)||+800 email@example.com|
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|Study Director:||Ekaterine Asatiani, MD||Incyte Corporation|