EUCTR2014-002408-26-AT进行中（未招募）1 期
A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
入选标准
- •-Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as
- •sarcomatoid or micropapillary change are acceptable
- •-Must have measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at baseline
- •- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0, 1, or 2
- •- Must have adequate bone marrow, liver, and renal function as described in protocol
- •- Negative pregnancy test (urine or serum beta human chorionic
- •gonadotropin [bhCG]) at Screening for women of child bearing potential who are sexually active
- •- Must have shown disease progression according to RECIST,
- •version 1.1, following prior chemotherapy for metastatic or
- •surgically unresectable urothelial cancer. Subjects who received
- •neoadjuvant or adjuvant chemotherapy and showed disease
- •recurrence or progression according to RECIST, version 1.1, within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting. These subjects will be
- •referred to as chemorefractory
- •subjects. (Subjects who have shown disease progression according to RECIST, version 1.1 following prior treatment with antiProgrammed
- •deathligand 1 (anti PDL1/PD1) antibodies are also 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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 126
排除标准
- •- Received chemotherapy, targeted therapies, definitive radiotherapy, or treatment with an investigational anticancer agent within 2 weeks (in the case of nitrosoureas and
- •mitomycin C, within 6 weeks; in the case of immunotherapy, within 4 weeks) before the first administration of study drug. Localized palliative radiation therapy (but should not include radiation to target lesions)
- •and ongoing bisphosphonates and denosumab, are permitted
- •- Has persistent phosphate level greater than upper limit of normal
- •(ULN) during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management
- •- Has a history of or current uncontrolled cardiovascular disease
- •- Females who are pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug and males who plan to father a child while enrolled in this study or within 5 months after the last dose of study drug
- •- Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, or Grade 1
- •neuropathy)
研究者
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