EUCTR2013-004810-16-PT进行中（未招募）1 期
PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 385
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. Provide written informed consent.
- •2. Is = 18 years
- •3. Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting the following criteria:
- •a. Phase 1 Expansion
- •i. Patient has failed 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 as shown:
- •- Group 1 (Enrollment Suspended as of Amendment 7): Patient has intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions.
- •- Group 2: Patient has intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR2 gene fusions, and has not received or received less than 1 cycle of prior chemotherapy (due to intolerance or patient refusal).
- •- 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.
- •- Group 4 (Enrollment suspended as of Amendment 7): Patient has intrahepatic or extrahepatic cholangiocarcinoma harboring FGFR abnormalities other than FGFR2 gene fusions
- •- Group 5: Patient has a primary CNS tumor harboring FGFR gene fusion or FGFR1 activating mutation and fulfills the criteria (i and ii).
- •- Group 6 (Enrollment Suspended as of Amendment 7): Patient has advanced urothelial carcinoma harboring FGFR3 fusions or FGFR3 activating mutations.
- •- Group 7: Patient has any tumor type not included in one of the prior groups, harboring FGFR2 amplification (no minimum number of copies).
- •- 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.
- •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 should 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 other FGFR2 rearrangements on tumor tissues or from ctDNA; it is requested that patients enrolled on this basis provide tumor tissues to Foundation Medicine if available from either archival samples or fresh tumor biopsy.
- •ii. Patient has been treated with at least one prior systemic gemcitabine and platinum-based chemotherapy. Patients with prior adjuvant gemcitabine-platinum chemotherapy are eligible if the patient had recurrence within 6 months of the last dose of the regimen.
- •iii. Patient has documentation of radiographic disease progression on the most recent prior therapy
- •4. Patient has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO criteria (2010) for brain tumors.
- •5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on Day 1 of Cycle 1
- •6. Able to take medications orally
- •7. Adequate organ function as defined by the following criteria:
- •a. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 ×upper limit of normal (ULN); if liver function abnormalities are due to unde
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 Screening.
- •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 depointes, 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.
研究者
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