Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors (NCT06022289) | Clinical Trial Compass
UnknownPhase 2
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors
China20 participantsStarted 2023-05-01
Plain-language summary
The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old; Gender unlimited
. Late stage, recurrent, or metastatic solid tumors confirmed by histology or cytology as unresectable by surgery.
. According to RECIST v1.1, there is at least one measurable lesion.
. Histological confirmation of FGFR1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.
. After standard treatment, the disease progresses, becomes intolerable, or standard treatment is ineffective, or there is no standard treatment plan.
. Has not previously used small molecule multi target inhibitors targeting the FGFR pathway (including arotinib, lenvatinib, sorafenib, apatinib, etc.).
. ECOG physical fitness status is 0-1.
. Expected survival time\>3 months.
Exclusion criteria
. Diagnosed within 5 years prior to the first administration as other malignant diseases outside of the current enrollment diagnosis (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ after radical resection).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Previously received selective FGFR inhibitor treatment.
. Those who have received any other study drug treatment or participated in intervention clinical studies within 28 days before the first administration. Or received anti-tumor drug treatment (including Chinese herbal medicine with anti-tumor indications) within 28 days before the first use of the study drug.
. Not fully recovered from toxicity and/or complications caused by any intervention measures before starting treatment (i.e. ≤ level 1 or reaching baseline, excluding fatigue or hair loss).
. Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist. For brain metastasis subjects who have previously received treatment, if their condition is stable (there is no evidence of imaging progression within at least 4 weeks before the first administration of the trial treatment), repeated imaging examinations confirm no evidence of new brain metastasis or enlargement of existing brain metastasis lesions, and steroid treatment is not required at least 14 days before the first administration of the trial treatment, they can participate in the trial. This exception does not include cancerous meningitis, which should be excluded regardless of its clinical stability.
. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
. The following laboratory parameters are abnormal: