The purpose of this research is to determine the benefit of pemigatinib in patients with advanced metastatic or surgically unresectable adenosquamous carcinoma of the pancreas who have progressed on previous therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Pemigatinib 4.5 mg tablets taken 3 times per day \[daily dose of 13.5 mg (3 tablets)\] for 14 consecutive days followed by 7 days off medication in 21-day cycles Doses will be self-administered at home. Participants will be instructed to take study medication at the same time each day, with or without food.
HonorHealth Research Institute
Scottsdale, Arizona, United States
Overall response rate of pemigatinib
Overall response rate of pemigatinib in patients with advanced metastatic or surgically unresectable ASCP who have progressed on previous therapy
Time frame: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
Progression free survival (PFS)
To determine progression free survival (PFS)
Time frame: Initiation of study treatment up to study completion, up to 2 years
Overall survival (OS)
To determine overall survival (OS)
Time frame: Initiation of study treatment up to study completion, up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE V4.0
To determine the overall safety (medical risk to the subject) and tolerability (the degree to which adverse effects can be tolerated by the subject) of pemigatinib in patients with advanced metastatic or surgically unresectable ASCP who have progressed on previous therapy
Time frame: Initiation of study treatment up to 12 cycles (each cycle is 21 days)
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