EUCTR2016-004743-37-BE进行中（未招募）1 期
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
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
- 25
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
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0
- •- 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
- •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
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