NCT03245736已完成2 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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
The purpose of the trial is to evaluate efficacy and safety of continued treatment with tisotumab vedotin.
详细描述
This is an open-label, multicenter trial to collect long-term safety and efficacy data and to provide ongoing access to tisotumab vedotin for patients with solid tumors who have completed a tisotumab vedotin base trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have either:
- •completed the base trial and have shown a clinical benefit of 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 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.
- •Acceptable renal function
- •Acceptable liver function
- •Acceptable hematological status
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •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.
- •Adequate contraception for women is defined as hormonal birth control or an intrauterine device (safe hormonal contraceptives include contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release). In countries where two highly effective methods of contraception are required this will be an inclusion criterion.
- •Male patients must be willing to use a latex condom during any sexual contact with females of childbearing potential during and for six months after the last infusion of tisotumab vedotin, even after having undergone a successful vasectomy.
- •In order to be considered as sterilized or infertile, a patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy; hysterectomy and bilateral ovariectomy) or be postmenopausal (12 months or more with no period prior to enrolment).
- •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
- •GEN701: 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 <
- •GEN702: Acceptable coagulation status defined as: INR ≤ 1.2 (without anticoagulant therapy), and aPTT ≤ ULN.
排除标准
- •Presence of CTCAE (Common Terminology 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.
研究组 & 干预措施
Tisotumab Vedotin
Experimental
All patients will be administered tisotumab vedotin (HuMax-TF-ADC) in 21 day treatment cycles.
干预措施: Tisotumab Vedotin (Drug)
结局指标
主要结局
Number of Participants Who Experienced a Treatment Emergent Adverse Event (TEAE)
时间窗: Day 1 to Week 24 plus 30 days
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment emergent adverse event (TEAE) is an AE occurring on or after the first dose of study medication or worsening during treatment period.
次要结局
- Number of Participants With Increased Prostate Specific Antigen (PSA)(Day 1 to Week 24 plus 30 days)
- Number of Participants With Increased Cancer Antigen (CA 125) Levels(Day 1 to Week 24 plus 30 days)
- Objective Response Rate(Day 1 to Week 24 plus 30 days)
研究者
研究点 (4)
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