Actively Recruiting
Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2022-12-15
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Pemigatinib in the Advanced Gastrointestinal Cancer With FGFR 1-3 Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 or older
- Histologically or cytologically confirmed unresectable advanced, recurrent or metastatic gastrointestinal cancer
- At least one measurable lesion according to RECIST v1.1
- Histologically confirmed FGFR1-3 alterations including amplification, mutation, fusion, or rearrangement
- Disease progression after prior standard therapy
- No previous use of small molecule multi-target inhibitors targeting the FGFR pathway
- ECOG performance status of 0 to 1
- Expected survival time greater than 3 months
- Sufficient organ functions
- Negative pregnancy test for women of childbearing age
- Use of contraception for patients and partners at risk of conception
You will not qualify if you...
- Diagnosed with malignant tumors other than gastrointestinal cancer within 5 years before first dose, except certain cured skin cancers and carcinoma in situ
- Prior receipt of selective FGFR inhibitors
- Participation in another clinical trial or use of anti-tumor drugs within 28 days before first dose
- Unrecovered toxicity or complications from prior treatments
- Known symptomatic central nervous system metastasis or carcinomatous meningitis
- History of allotransplantation or allogeneic hematopoietic stem cell transplantation
- Abnormal laboratory values including high serum phosphate, abnormal calcium, or low potassium levels
- Known HIV infection or positive immune test
- Severe active infection or poor clinical control
- Pleural effusion, ascites, or pericardial effusion requiring drainage
- Active hepatitis B or C infection
- Significant or uncontrolled heart diseases
- Clinically significant ECG changes or QTcF interval over 480 ms
- Uncontrolled hypertension or history of hypertensive crisis
- Liver conditions including hepatic encephalopathy or cirrhosis with Child-Pugh B or C
- Major surgery within 4 weeks before first dose or planned during treatment
- Pregnancy, lactation, or expected conception during study period
- Radiotherapy within 4 weeks before first dose
- History of calcium and phosphorus metabolism disorders with ectopic soft tissue calcification
- Significant corneal or retinal disease
- Use of potent CYP3A4 inhibitors or inducers within 14 days before first dose
- Known allergy to pemigatinib or its ingredients
- Unable or unwilling to swallow pemigatinib or with digestive diseases affecting drug absorption or metabolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
W
Wei Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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