A multi-center, open-label trial investigating the efficacy and safety of continued treatment with tisotumab vedotin in patients with solid tumors known to express tissue factor

Genmab A/S0 个研究点目标入组 25 人开始时间: 2017年4月24日最近更新: 2019年4月30日

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: 25

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

入选标准

•- Patients must have completed one of the base trials and have shown a clinical benefit of stable disease (SD) or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or not completed treatment as defined in the base protocol for reasons that are not considered critical and unmanageable for the safety of the patient (as evaluated by the investigator and/or the sponsor) and the patient clearly showed response of partial response (PR) or better.
•- Patients must not have experienced radiographic disease progression or clinical signs of symptoms of instability requiring urgent intervention.
•- Patients must not have received any other anti-cancer treatment (including surgery, radiation or systemic chemotherapy) since the base trial.
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•- A negative serum pregnancy test (if female and aged between 18-55 years old).
•- Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for six months after the last infusion of tisotumab vedotin.
•- 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 as defined in the applicable base protocol:
•oGEN701: Acceptable coagulation status: International normalized ratio (INR) = 1.2 (without anticoagulant therapy), and activated partial thromboplastin time (aPTT) = 1.25 ULN; patients on stable doses of therapeutic anti-coagulative treatment for = 8 weeks (e.g., warfarin) must have an INR < 3.
•oGEN702: Acceptable coagulation status defined as: INR = 1.2 (without anticoagulant therapy), and aPTT = ULN.
•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 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 17

排除标准

•- Presence of CTCAE (Common Toxicity Criteria for Adverse Events) grade = 2 peripheral neuropathy.
•- Clinically significant active viral, bacterial or fungal infection requiring intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or oral treatment with anti-infective therapy that has been administered less than one week prior to first dose in this trial; prophylactic anti-infective therapy which is given without clinical symptoms is allowed.
•- Ongoing acute or chronic inflammatory skin disease.
•- Women who are breast feeding.

研究者

发起方

Genmab A/S

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