A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Incyte Corporation0 个研究点目标入组 111 人开始时间: 2019年7月17日最近更新: 2024年3月18日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Incyte Corporation
入组人数: 111

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Age 18 years or older, inclusive at the time of signing the informed
•consent; a legally minor participant from Japan needs written parental
•or legal guardian's consent.
•2. Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV per the AJCC Cancer Staging Manual, 8th ed; AJCC 2018) or is surgically unresectable.
•3. Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors). Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measureable if progression has been clearly demonstrated in the lesion.
•4. Documentation of an FGFR1-3 gene mutation or fusion/rearrangement (Section 8.5.1 and Appendix C of the protocol). Participants will be assigned to 1 of 3 cohorts:
•Cohort A: FGFR1-3 in-frame fusions; any FGFR2 rearrangement;
•FGFR/3 rearrangement with known partner* (n = 60)
•Cohort B: Known or likely activating mutations (excluding kinase domain) in FGFR1-3included in Appendix C of the protocol (n = 90)
•Cohort C: FGFR1-3 known activating mutations in kinase domain;
•FGFR1-3 putatively activating mutations; other FGFR1/3
•rearrangements* (not eligible for Cohort A; ( n= 20) *Only FGFR fusions or rearrangements with an intact kinase domain are eligible.
•5. Must have objective progression after at least 1 prior therapy, and must have no therapy available that is likely to provide clinical benefit. Participants who are intolerant to or decline the approved therapy are eligible only if they have no therapy available that is likely to provide clinical benefit.
•6. ECOG performance status 0 to 2.
•7. Baseline archival tumor specimen (if less than 12 months from date of screening) or willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a tumor block or approximately 15 unstained slides from biopsy or resection of primary tumor or metastasis.
•8. Willingness to avoid pregnancy or fathering children based on the criteria below.
•a. Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last dose of study drug(s)/treatment and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A of the protocol) should be communicated to the participants and their understanding confirmed.
•b. Women of childbearing potential must have a negative serum pregnancy test at screening and before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix A of the protocol) should be communicated to the participants and their understanding confirmed.
•c. Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR = 12 months of amenorrhea) are eligible.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

排除标准

•1. Prior receipt of a selective FGFR inhibitor.
•2. Receipt of anticancer medications or investigational drugs for any indication or reason within 28 days before first dose of pemigatinib. Participants must have recovered (= Grade 1, as per CTCAE v5.0, or at pretreatment baseline) from AEs from previously administered therapies (excluding alopecia).
•3. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
•4. Candidate for potentially curative surgery.
•5. Current evidence of clinically significant corneal (including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis) or retinal disorder (including, but not limited to, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination.
•6. Radiation therapy administered within 2 weeks of enrollment/first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 1-week washout is permitted for palliative radiation to non-CNS disease.
•7. Untreated brain or CNS metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases). Participants who have previously treated and clinically stable brain or CNS metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and if they are on a stable or decreasing dose of corticosteroids for at least 1 week.
•Note: Participants with progressing primary brain tumors are allowed if they have no new neurological symptoms and are on a stable or decreasing dose of corticosteroids for at least 1 week.
•8. Known additional malignancy that is progressing or requires active 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

发起方

Incyte Corporation

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