CTRI/2021/11/038016进行中（未招募）2 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 - DDI Sub study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
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
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 [b-hCG]) 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.
- •Participants 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 participants will be referred to as chemo-refractory participants. (Participants who have shown disease progression according to RECIST, version 1.1 following prior treatment with anti-Programmed death-ligand 1 (anti PDL1/PD1) antibodies are also eligible)
- •For DDI substudy
- •- Disease progression following prior chemotherapy for metastatic or surgically unresectable urothelial cancer. Participants who received neoadjuvant or adjuvant chemotherapy and showed disease recurrence or progression within 12 months of the last dose are considered to have received chemotherapy in the metastatic setting.
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
- •- 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, breast-feeding, 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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