recurrent glioma :
Conditions
Interventions
Experimental Group:Adult patients receive oral pemigatinib 13.5 mg once daily on days 1-14/21 days. Pediatrics receive pemigatinib at the approximate body surface area-adjusted adult dose (13.5mg/1.73
Sponsors
Sanbo Brain Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: (1) Sign a written informed consent prior to the implementation of any trial related procedures; (2) Histopathologically confirmed glioma; (3) Harboring FGFR1-3 variants, including but not limited to amplification, mutation, fusion or rearrangement; at least 3 months away from the last dose of radiotherapy (unless there are new tumor lesions or histopathological evidence of tumor recurrence in the radiation field), and recovered from the last dose of chemotherapy (excluding hair loss and pigmentation); (4) Progression after at least one anti-tumor radiotherapy or chemotherapy; (5) If patient received re-resection when recurrence, recovery is required before enrollment, and medication can only be started after at least 4 weeks from the last surgery or at least 1 week from biopsy; (6) No previous use of selective FGFR inhibitors (including but not limited to erdatinib, infitinib, forbatinib, etc.); (7) At least 1 measurable or evaluable lesion according to RANO evaluation criteria; (8) Life expectancy = 12 weeks; (9) KPS=60 (age >12 years) or Lansky=60 (age =12 years); (10) Age 0-70 years old; (11) Adequate organ and bone marrow function.
Exclusion criteria
Exclusion criteria: (1) Pregnant and lactating patients; (2) Participated in other drug clinical trials within four weeks; (3) Uncontrolled concurrent diseases, including but not limited to: a.HIV infected persons (HIV-positive); b. Severe infections that are active or poorly controlled clinically; c. Evidence of serious or uncontrolled systemic disease (e.g., severe mental illness, epilepsy or dementia, unstable or uncompensable respiratory, cardiovascular, liver or kidney disease, uncontrolled hypertension (i.e., CTCAE2 level or greater after medication); (4) Previous use of other selective FGFR inhibitors; (5) Severe abnormality of calcium and phosphorus metabolism: a. Serum phosphate > upper limit of normal; b. Serum calcium is outside the normal range, or when serum albumin is outside the normal range, the serum albumin-corrected calcium concentration is outside the normal range; c. Potassium level < lower limit of normal value;Potassium levels can be corrected by supplementation at the time of screening. (6) Corneal or retinal diseases; (7) Significant digestive disorders that may interfere with absorption, metabolism, or excretion; (8) The subject has a history of vitamin D deficiency and requires a suprapsiologic dose of vitamin D supplementation (except vitamin D dietary supplements); (9) Known allergy to pemigatinib or any drug associated with pemigatinib ; (10) Other conditions deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;disease control rate;duration of response;overall survival;safety;tolerance; | — |
Countries
China
Contacts
Public ContactJunping Zhang
Sanbo Brain Hospital Capital Medical University
Outcome results
None listed