Status and phase
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About
This study is a prospective single-arm phase II study to evaluate the efficacy and safety of Pemigatinib in the advanced gastrointestinal cancer with FGFR 1-3 alterations and failed standard therapy.
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Volunteers
Inclusion criteria
Exclusion criteria
Diagnosed with malignant tumors other than gastrointestinal cancer within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ
Prior receipt of selective FGFR inhibitors
Have received any other investigational drug or participated in another interventional clinical trial within 28 days before the first dose, or have received anti-tumor drug treatment within 28 days before the first dose (including Chinese herbal medicine with anti-tumor indications)
Have not recovered ( ≤ grade 1 or reaching the baseline, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment
Known symptomatic central nervous system metastasis and/or carcinomatous meningitis.
Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation
Abnormal laboratory parameters listed below:
Known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results
Presence of severe infection in the active phase or with poor clinical control
Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage
Acute or chronic active hepatitis B or C infection
Clinically significant or uncontrolled heart diseases, including unstable angina, acute myocardial infarction within 6 months before the first dose, grade III/IV congestive heart failure (New York Heart Association), and uncontrolled arrhythmia (patients with pacemakers or with atrial fibrillation but well controlled heart rate are allowed)
ECG changes or medical history considered clinically significant by the investigator, QTcF interval > 480 ms at screening, JTc interval can be used instead of QTc interval (in such cases, JTc must be ≤ 340 ms) for patients with intraventricular conduction block (QRS interval > 120 ms)
Uncontrolled hypertension (systolic pressure > 160 mmHg or diastolic pressure > 100 mmHg) after the optimal medical treatment, or a history of hypertensive crisis or hypertensive encephalopathy
Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis with Child-Pugh grade B or C
Have received a major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose, or will receive a major surgery during the study treatment period
Not fully recovered from toxicity and/or complications of a major surgery before the study treatment
Pregnant or lactating women, or patients expected to conceive or give birth during the study period from the screening to the completion of the safety follow-up visit (90 days after the last dose for male subjects)
Have received radiotherapy within 4 weeks before the first dose.
History of disorders of calcium and phosphorus metabolism or systemic electrolyte metabolism imbalance with ectopic calcification of soft tissues (excluding calcification of soft tissues such as skin, kidneys, tendon, or blood vessels without systemic electrolyte metabolism imbalance caused by injury, disease, and old age)
Clinically significant corneal or retinal diseases confirmed by ophthalmological examination
Prior receipt of any potent CYP3A4 inhibitor or inducer within 14 days or 5 half lives (whichever is shorter) before the first dose. Ketoconazole is allowed for external use
Known allergic reactions to pemigatinib or excipients of pemigatinib
Unable or unwilling to swallow pemigatinib or are suffering from significant digestive system diseases that may interfere with absorption, metabolism, or excretion
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Wei Lu
Data sourced from clinicaltrials.gov
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