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 range18 Years

SexALL

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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).
✕. 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:
✕. Serum phosphate\>ULN.

What they're measuring

Progression-free Survival 2/Progression-free Survival 1(PFS2/PFS1)

Timeframe: Through study completion, an expected average of 1 year.

Trial details

NCT IDNCT06022289

SponsorTianjin Medical University Second Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-01

Contact for this trial

HaiTao Wang, Ph.D

+86-022-88326385 peterrock2000@126.com

View on ClinicalTrials.gov More Solid Tumor trials