EUCTR2016-001962-27-FR进行中（未招募）1 期
Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
- •-Measurable Metastatic triple negative breast cancer (TNBC).
- •-Patients with CA6-positive disease.
- •-Patients received at least 1 prior chemotherapy regimen but no more than 3 for advanced/metastatic disease.
- •-Prior anticancer therapy must have contained anthracycline (eg, doxorubicin), if not contraindicated, and a taxane (eg, docetaxel, paclitaxel) in an adjuvant/neo-adjuvant or metastatic setting.
- •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 52
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •-Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •-Patient less than 18 years old.
- •-Pregnant or breast-feeding women.
- •-Patients with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of study drug.
- •-Wash out period of less than 3 weeks or 5 half-lives from previous antitumor chemotherapy, immunotherapy, or any investigational treatment.
- •-History of brain metastasis (other than totally resected or previously irradiated and nonprogressive/relapsed), spinal cord compression or carcinomatous meningitis, or new evidence of brain leptomeningeal disease.
- •-Prior treatment with eribulin as last prior therapy or prior maytansinoid treatments (DM1 or DM4 antibody-drug conjugates [ADCs]).
- •-Known intolerance to infused protein products including other monoclonal antibodies and ADCs.
- •-Poor bone marrow reserve and/or poor organ function.
- •-Symptomatic peripheral neuropathy Grade =2.
- •-Previous history of chronic corneal diseases (even if asymptomatic) or unresolved acute nonrecurrent corneal conditions.
- •-Patients wearing contact lenses who are not willing to stop wearing them for the duration of the study.
- •-Medical conditions requiring concomitant administration of strong CYP3A4 inhibitors, unless it can be discontinued at least 2 weeks before 1st administration of SAR566658.
- •-Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid.
研究者
相似试验
已完成
2 期
Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancerbreast cancerNL-OMON46882Sanofi-aventis5
进行中（未招募）
1 期
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast CancerCancerEUCTR2016-001962-27-CZSanofi-aventis recherche & développement63
进行中（未招募）
1 期
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast CancerCancerEUCTR2016-001962-27-ESSanofi-aventis recherche & développement23
进行中（未招募）
1 期
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast CancerCancerEUCTR2016-001962-27-NLSanofi-aventis recherche & développement23
进行中（未招募）
1 期
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients with CA6 Positive Metastatic Triple Negative Breast CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)CancerEUCTR2016-001962-27-BESanofi-aventis recherche & développement62