NL-OMON48846已完成2 期
PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS - TPU-TAS-120-101
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provide written informed consent., 2. Is >= 18 years (or according the
- •country's regulatory definition for legal adult age)., 3. Has histologically or
- •cytologically confirmed, locally advanced, metastatic cancer meeting the
- •following criteria:
- •a.Phase 1 Expansion , i.Patient has failed ((or in the case of Group
- •2, failed or refused) all standard therapies or standard therapy does not exist
- •or is not tolerated. , ii. Patient is eligible for 1 of the following
- •enrollment groups, based on diagnosis, prior therapy, and FGF/FGFR aberrations
- •a. Group 1 (Enrollment Suspended as of Amendment 7): Patient has
- •intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions.
- •b. Group 2: Patient has intrahepatic or extrahepatic
- •cholangiocarcinoma withharboring FGFR2 gene fusions or other FGFR2 , and has
- •not received or received less than 1 cycle of prior chemotherapy (due to
- •intolerance or patient refusal).
- •c. Group 3 (Enrollment Suspended as of Amendment 7): Patient has
- •intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions
- •and has received prior treatment with FGFR inhibitors.
- •d. Group 4 (Enrollment suspended as of Amendment 7): Patient has
- •intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR abnormalities,
- •other than FGFR2 gene fusions (for example, mutations, rearrangements, or
- •amplifications).
- •e. Group 5: Patient has a primary CNS tumor harboring FGFR gene fusion
- •or FGFR1 activating mutation and fulfills the following criteria (i and ii):,
- •i. Patients who are presenting in recurrence or relapse must have at least one
- •measurable enhancing mass lesion with 2 perpendicular diameters of at least 10
- •mm documented on baseline contrast magnetic resonance imaging (MRI)
- •(gadolinium-based MRI).
- •ii. Patients should be on a stable dose of steroids for at least
- •7 days prior to obtaining the baseline contrast MRI of the brain and at least 7
- •days prior to starting study drug. , f. Group 6 (Enrollment Suspended as of
- •Amendment 7): Patient has advanced urothelial carcinoma harboring FGFR3 fusions
- •or FGFR3 activating mutations.
- •g. Group 7: Patient has any tumor type not included in one of the prior
- •groups, harboring FGFR2 amplification (no minimum number of copies).
- •h. Group 8 (Enrollment Suspended as of Amendment 7): Patient has any
- •tumor type not included in one of the prior groups, harboring FGFR gene fusions
- •or activating mutations.
- •, b. Phase 2, i. Patient has histologically or cytologically confirmed,
- •locally advanced, metastatic, unresectable iCCA harboring FGFR2 gene fusions or
- •other FGFR2 rearrangements based on results from either of the following:
- •a. Testing by Foundation Medicine:
- •i. As part of study pre-screening; or
- •ii. Previously tested by Foundation Medicine; in this
- •case, it is requested that
- •tumor tissue be provided to Foundation Medicine if available.
- •b. Local laboratory testing using next generation sequencing [NGS],
- •fluorescence in situ
- •hybridization [FISH], or other assays that can determine FGFR2 gene fusions or
- •FGFR2 rearrangements on tumor tissues or from ctDNA. It is requested that
- •enrolled on this basis provide tumor tissues to Foundation Medicine, if
- 另有 3 项未显示
排除标准
- •1. History and/or current evidence of clinically significant non-tumor related
- •alteration of calcium-phosphorus homeostasis., 2. History and/or current
- •evidence of clinically significant ectopic mineralization/calcification. , 3.
- •History and/or current evidence of clinically significant retinal disorder
- •confirmed by retinal examination. , 4. History or current evidence of serious
- •uncontrolled ventricular arrhythmias.
- •5. Fridericia*s corrected QT interval (QTcF) > 470 ms on ECG conducted during
- •6. Treatment with any of the following within the specified time frame prior to
- •the first dose of TAS-120:, a. Major surgery within the previous 4 weeks (the
- •surgical incision should be fully healed prior to the first dose of TAS 120).,
- •b. Radiotherapy for extended field within 4 weeks or limited field radiotherapy
- •within 2 weeks. , c. Patients with locoregional therapy, e.g., transarterial
- •chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation
- •within 4 weeks. , d. Any noninvestigational anticancer therapy within 3 weeks
- •or have not recovered from side effects of such therapy prior to TAS 120
- •administration (mitomycin within prior 5 weeks). , • Targeted therapy or
- •immunotherapy within 3 weeks or within 5 half-lives (whichever is shorter) , e.
- •Any investigational agent received within 5 half-lives of the drug or 4 weeks,
- •whichever is shorter. Concurrent participation in an observational study may be
- •allowed after review by the Sponsor*s Medical Monitor.
- •f. Patients with prior FGFR-directed therapy., 7. A serious illness or
- •medical condition(s) including, but not limited to, the following:, a. Known
- •brain metastasis (not including primary brain tumors) unless patient is
- •clinically stable for >= 1 month., b. Known acute systemic infection., c.
- •Myocardial infarction, severe/unstable angina, symptomatic congestive heart
- •failure (New York Heart Association [NYHA] Class III or IV (see Appendix D, New
- •York Heart Association [NYHA] Classification) within the previous 2 months; if
- •> 2 months, cardiac function must be within normal limits and the patient must
- •be free of cardiac-related symptoms., d. Chronic nausea, vomiting, or diarrhea
- •considered to be clinically significant in the opinion of the investigator., e.
- •Congenital long QT syndrome, or any known history of torsade de pointes, or
- •family history of unexplained sudden death. , f. Other severe acute or chronic
- •medical or psychiatric condition or laboratory abnormality that in the judgment
- •of the investigator would make the patient inappropriate for entry into this
- •study., 8. Patients with a history of another primary malignancy that is
- •currently clinically significant, and has potential for metastases or currently
- •requires active intervention (except for gonadotropin-releasing hormone (GnRH)
- •or luteinizing hormone-releasing hormone (LH-RH) agonists in prostate cancer or
- •adjuvant hormonal therapy in breast cancer)., 9. Pregnant or lactating female.
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