A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1 3 Alterations (FIGHT-209)

Incyte Corporation0 个研究点目标入组 164 人开始时间: 2022年2月18日最近更新: 2024年8月26日

试验速览

阶段: 1 期
状态: 招募中
发起方: Incyte Corporation
入组人数: 164

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•1. Ability to comprehend and willingness to sign a written ICF for the study. A legally authorized representative can sign the statement of informed consent for the participant. For Germany and France: Only participants who can provide their own consent are able to participate in this clinical study.
•2. Participants aged 18 years or older at the time of signing the ICF.
•3. Histological, cytological, or molecular confirmation of recurrent GBM or other gliomas, circumscribed astrocytic gliomas, and glioneuronal or neuronal tumors that have recurred.
•a. For Cohort A: Prior, histopathologically proven, WHO Grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of Grade 4 GBM per WHO 2021 (astrocytic glioma requires presence of either amplification of EGFR,whole chromosome 7 gain and whole chromosome 10 loss, or TERT promoter mutation) that has recurred or progressed on or after treatment with at least 1 line of standard-of-care therapy.
•b. For Cohort B: Prior, histopathologically proven, per WHO criteria, gliomas other than GBM (eg, IDH-mutant astrocytoma, IDH-mutant and 1p/19q codeleted oligodendroglioma), circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors that are recurrent or have progressed on or after at least 1 line of standard-of-care therapy (eg, radiotherapy and/or treatment with an alkylating chemotherapy such as TMZ, CCNU, or BCNU-containing chemotherapy).
•4. Radiographically measurable disease (per RANO). Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion.
•5. Karnofsky performance status = 60.
•6. Life expectancy = 12 weeks.
•7. Documentation of an actionable FGFR1-3 gene alteration (defined mutations, gene fusion/rearrangements, or in-frame deletions) from tissue or cfDNA from a qualified laboratory such as FMI or Guardant Health may be acceptable after review by medical monitor. Participants with known FGFR resistance mutations are not eligible.
•a. Cohort A: Participants with histopathologically proven, WHO Grade 4, IDH-wild-type GBM OR molecular diagnosis of IDH-wild-type, diffuse astrocytic glioma with molecular features of Grade 4 GBM per WHO 2021 (astrocytic glioma requires presence of either amplification of EGFR, whole chromosome 7 gain and whole chromosome 10 loss, or TERT promoter mutation) that are recurrent, harboring FGFR1-3 fusions/or other rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, or FGFR1/3 rearrangement with known partner) or with a defined FGFR1-3 activating mutation or in-frame deletion. Only participants with FGFR fusions or rearrangements with an intact kinase domain are eligible.
•b. Cohort B: Participants with other histopathologically proven, per WHO criteria, gliomas other than GBM (eg, IDH-mutant astrocytoma, IDHmutant and 1p/19q codeleted oligodendroglioma), circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors that are recurrent, harboring FGFR1-3 fusions/or other rearrangements (FGFR1-3 in-frame fusions, any FGFR2 rearrangement, FGFR1/3 rearrangement with known partner) or with a defined FGFR1-3 activating mutation or in-frame deletion. Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
•8. MRI-documented objective progression after prior therapy and must have no therapy available that is likely to provide clin

排除标准

•1. Prior receipt of an FGFR inhibitor.
•2. Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of study drug. Participants must have recovered (= Grade 1) from AEs from previously administered therapies.
•3. Participants may have had treatment for an unlimited number of prior relapses but must not have had prior bevacizumab or other VEGF/VEGFR inhibitors.
•4. Concurrent anticancer therapy.
•5. Candidate for potentially curative surgery.
•6. Dexamethasone (or equivalent) > 4 mg daily at the time of study registration (higher dose of steroid for symptom control is allowed during the study).
•7. Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
•8. Diffuse leptomeningeal disease.
•9. Radiation therapy administered within 12 weeks before enrollment/first dose of study drug. An interval of at least 12 weeks after prior radiotherapy is required unless there is either histopathological confirmation of recurrent tumor or new enhancement on MRI outside the radiotherapy field.
•10. Known additional malignancy that is progressing or requires active systemic treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•11. Participants with laboratory values at screening defined in Table 7.

研究者

发起方

Incyte Corporation

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