NL-OMON53632尚未招募2 期
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) - FIGHT-209
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 8
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Ability to comprehend and willingness to sign a written ICF for the
- •study. For Germany: Only participants who can provide their own consent are
- •able to participate in this clinical study.
- •2. Male and female participants aged 18 years or older at the time of signing
- •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
- •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
排除标准
- •1. Prior receipt of a selective 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.
研究者
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