NL-OMON55515已完成3 期
A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations - THOR (42756493BLC3001)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
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. >=18 years of age (or the legal age of consent in the jurisdiction in which
- •the study is
- •taking place)
- •2. Histologic demonstration of transitional cell carcinoma of the urothelium.
- •Minor components (<50% overall) of variant histology such as glandular or
- •squamous differentiation, or evolution to more aggressive phenotypes such as
- •sarcomatoid or micropapillary change are acceptable
- •3. Criterion amended per Amendment 2:
- •3.1 Metastatic or surgically unresectable urothelial cancer
- •4. Documented progression of disease, defined as any progression that requires
- •a change in
- •treatment, prior to randomization
- •5. Criterion modified per Amendment 5:
- •5.3 Cohort 1: Prior treatment with an anti-PD-(L)1 agent as monotherapy or as
- •combination therapy; no more than 2 prior lines of systemic treatment. Prior
- •treatment with an anti-PD-(L)1 agent could have been given as neo-adjuvant,
- •adjuvant, or in metastatic line of treatment as frontline or maintenance
- •therapy, as follows:
- •* together with chemotherapy or as maintenance therapy
- •* together with chemotherapy in metastatic setting
- •* for superficial cancer (early disease/non-muscle invasive bladder cancer),
- •OR in neo-adjuvant OR adjuvant setting. If these subjects did not relapse
- •within a year of their last dose of anti-PD-(L)1, this will not be counted as a
- •prior line of systemic treatment. These subjects will however still be eligible
- •only for Cohort 1.
- •Cohort 2: No prior treatment with an anti-PD-(L)1 agent; only 1 line of prior
- •Note: Subjects who received neoadjuvant or adjuvant chemotherapy or
- •immunotherapy and showed disease progression within 12 months of the last dose
- •are considered to have received systemic therapy in the metastatic setting.
- •6. Subjects must meet appropriate molecular eligibility criteria (as determined
- •by central laboratory screening or local or by local historical test results
- •(from tissue or blood) performed at a Clinical Laboratory Improvement
- •Amendments (CLIA)-certified or regional equivalent laboratory using the
- •following methods: local next-generation sequencing (NGS), direct digital
- •counting methods, or the Qiagen Therascreen FGFR Rotor-Gene Q (RGQ) reverse
- •transcription polymerase chain reaction (RT-PCR) test.
- •Tumors must have at least 1 of the following translocations: FGFR2-BICC1,
- •FGFR2-CASP7, FGFR3-TACC3, FGFR3-BAIAP2L1; or 1 of the following FGFR3 gene
- •mutations: R248C, S249C, G370C, Y373C.
- •7. ECOG performance status Grade 0, 1, or 2 (Attachment 1)
- •8. Criterion amended per Amendment 2:
- •8.1 Criterion modified per Amendment 3:
- •8.2.Criterion modified per Amendment 4:
- •8.3 Criterion modified per Amendment 5:
- •8.4 Adequate bone marrow, liver, and renal function:
- •a. Bone marrow function (without the support of cytokines or
- •erythropoiesis-stimulating
- •agent in preceding 2 weeks):
- •* Absolute neutrophil count (ANC) >1,500/mm3
- •* Platelet count >75,000/mm3 (>=100,000/mm3 for Cohort 1 subjects at sites
- 另有 7 项未显示
排除标准
- •1. Treatment with any other investigational agent or participation in another
- •clinical study with therapeutic intent within 30 days prior to randomization.
- •2. Criterion amended per Amendment 2:
- •2.1 Criterion modified per Amendment 3:
- •2.2 Active malignancies (ie, requiring treatment change in the last 24 months).
- •only allowed exceptions are:
- •* urothelial cancer.
- •* skin cancer treated within the last 24 months that is considered completely
- •* localized prostate cancer with a Gleason score of 6 (treated within the last
- •24 months or untreated and under surveillance).
- •* localized prostate cancer with a Gleason score of 3+4 that has been treated
- •than 6 months prior to full study screening and considered to have a very low
- •of recurrence.
- •3. Symptomatic central nervous system metastases.
- •4. Received prior FGFR inhibitor treatment.
- •5. Known allergies, hypersensitivity, or intolerance to erdafitinib or its
- •6. Criterion amended per Amendment 2:
- •6.1 Criterion modified per Amendment 3.
- •6.2 Current central serous retinopathy (CSR) or retinal pigment epithelial
- •of any grade.
- •7. History of uncontrolled cardiovascular disease including:
- •a. unstable angina, myocardial infarction, ventricular fibrillation, Torsades de
- •Pointes, cardiac arrest, or known congestive heart failure Class III-V
- •(Attachment 3) within the preceding 3 months; cerebrovascular accident or
- •transient ischemic attack within the preceding 3 months.
- •b. QTc prolongation as confirmed by triplicate assessment at screening
- •(Fridericia;
- •QTc >480 milliseconds).
- •c. Pulmonary embolism or other venous thromboembolism (VTE) within the
- •preceding 2 months.
- •8. Known active AIDS (human immunodeficiency virus (HIV) infection), unless the
- •subject has been on a stable anti-retroviral therapy regimen for the last 6
- •more, has had no opportunistic infections in the last 6 months, and has CD4
- •9. Criterion amended per Amendment 3: 9.1 Known active hepatitis B or C
- •infection (unless polymerase chain reaction
- •[(PCR]-negative [according to local laboratory range] on all available tests
- •for the past
- •10. Criterion amended per Amendment 3:
- •10.1 Not recovered from reversible toxicity of prior anticancer therapy (except
- •toxicities which are not clinically significant such as alopecia, skin
- •discoloration,
- •neuropathy, hearing loss).
- •11. Impaired wound healing capacity defined as skin/decubitus ulcers, chronic
- •leg ulcers,
- •known gastric ulcers, or unhealed incisions.
- •12. Major surgery within 4 weeks before randomization.
- •13. Criterion amended per Amendment 2: 13.1 Criterion modified per Amendment 3:
- •13.2 Any condition for which, in the opinion of the investigator, participation
- •would not be in the best interest of the subject (eg, compromise the
- •well-being) or that could prevent, limit, or confound the protocol-specified
- 另有 2 项未显示
研究者
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