A Phase 2, randomised, open label, multicentre study to evaluate efficacy and safety of an intraperitoneal a-emitting radionuclide therapy (Radspherin®) in patients with peritoneal carcinomatosis from colorectal carcinoma following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) - RAD-18-004

Oncoinvent AS0 个研究点目标入组 102 人开始时间: 2023年11月30日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Oncoinvent AS
入组人数: 102

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

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP)., For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment., For females of childbearing potential: agreement to use at least one of the following highly effective (failure rate < 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Note: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment., For non-sterile males whose female partner is of childbearing potential: agreement to use condom during the treatment period and for at least 6 months if they received Radspherin®. The female partner should use at least one of the following highly effective (failure rate < 1%) methods of contraception during the same period: 1) Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2) Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. 3) Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment., Non-sterile males must agree to refrain from donating sperm for the entire treatment period and for up to 6 months after the dose of IMP., Age = 18 years., Histologically confirmed colorectal carcinoma. In case of recurrent metastatic disease from colorectal carcinoma to the peritoneal cavity, where the clinical diagnosis seems clear, a confirmative frozen section biopsy of the p

排除标准

•Presence of peritoneal metastasis originating from appendix vermiformis, other synchronous metastatic lesions, symptomatic central nervous system metastases. Suspicion of non-regional (e.g. retroperitoneal, thoracic) metastatic lymph nodes on imaging., Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patient or interfere with the evaluation of the safety of the investigational medicinal product., Any patient who, in the investigator’s opinion, was not able to comply with study procedures. Presence of any medical or psychological condition that would preclude participation in the study or compromise the ability of the patient to give informed consent., Known hypersensitivity to any of the excipients in the study drug., Rectal carcinoma previously treated with pelvic radiation., Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator’s judgement, patient history and diagnostic images., Pregnant or lactating (nursing) women., Active infections requiring antibiotics and/or physician monitoring, or recurrent fever >38.0 °C associated with a clinical diagnosis of active infection., Administration of an investigational medicinal product within 4 weeks or at least 5 times the half-life of the product, prior to enrolment., Concurrent administration of any other cancer therapy other than the planned study treatment within 4 weeks prior to and up to 4 weeks after the surgery., Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ, or in situ Stage 1 synchronous endometrial cancer)., Concurrent congestive heart failure or prior history of New York Heart Association Class III/IV cardiac disease.

研究者

发起方

Oncoinvent AS

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