A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
Gastric and Colorectal Cancer Clinical Trial
Official title: A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
Clinical Trial Summary
This study is a prospective single-arm phase II clinical study. Advanced gastric and
colorectal tumor patients with FGFR 1-3 alterations who have failed standard therapy will be
enrolled in this study once they have signed the informed consent form (ICF) and been
identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a
day (QD) orally following a 2-week administration/1-week interruption regimen. They will be
dosed until disease progression or intolerable toxicity. During treatment, clinical tumor
imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and
then every 9 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.