A single arm, multicenter, international trial of tisotumab vedotin (HuMax®-TF-ADC) in previously treated, recurrent or metastatic cervical cancer - NA

Genmab A/S0 个研究点目标入组 100 人开始时间: 2018年3月13日最近更新: 2021年8月10日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Genmab A/S
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

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: Female

入选标准

•Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology, that:
•1. Have experienced disease progression during or after treatment with:
•- Paclitaxel+cisplatin or carboplatin OR
•- Paclitaxel+topotecan,
•in combination with bevacizumab unless patients are ineligible for bevacizumab treatment according to local standards.
•2. Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in combination with radiation therapy is not considered a prior systemic regimen.
•3. Are not candidates for curative therapy, including but not limited to, radiotherapy or exenterative surgery.
•Age = 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•Life expectancy of at least three months
•A negative serum pregnancy test for patients of reproductive potential
•Patients of reproductive potential must agree to use adequate contraception during and for 6 months after the last IMP administration
•Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out
•Acceptable coagulation status:
•o International normalized ratio (INR) = 1.2 (without anti-coagulation therapy).
•o Activated partial thromboplastin time (aPTT) = 1.25 ULN.
•o Patients on anti-coagulation therapy (e.g., warfarin) must be on a steady dose (no active titration) for at least 4 weeks prior to screening and must have an INR = 2.5 for eligibility. Concurrent use of prophylactic AcetylSalicylic Acid (ASA, e.g., aspirin) for patients on anti-coagulation therapy (e.g., warfarin) is prohibited.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

排除标准

•Known past or current coagulation defects
•Ongoing major bleeding
•Clinically significant cardiac disease
•Other cancer: Known past or current malignancy other than inclusion diagnosis

研究者

发起方

Genmab A/S

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