EUCTR2020-002949-42-IT进行中（未招募）1 期
A pilot study of chlorambucil in pre-treated metastatic pancreatic adenocarcinoma patients bearing a germ line BRCA or other DNA Defects Repair (DDR) mutations. - SALE
OSPEDALE SAN RAFFAELE0 个研究点目标入组 30 人开始时间: 2021年5月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- All
入选标准
- •1)Pathologically confirmed pancreatic adenocarcinoma
- •2)Age = 18 years
- •3)ECOG PS 0-2
- •4)Stage IV disease
- •5)Identified genetic aberrations that are associated with homologous recombination deficiency (HRD)
- •a)Cohort A: Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious
- •b)Cohort B: BRCA1 or BRCA2 mutations that are considered to be of uncertain/unknown significance (VUS)
- •c)Cohort C: Patients with other identified genetic aberrations that are associated with HRD
- •6)adequate PFS during previous platinum-based chemotherapy for at least 4 months before progression
- •7)Screening laboratory values:
- •Leukocytes > 3000/mmc
- •Thrombocytes > 150000/mmc
- •Hemoglobin > 10 g/dl
- •Creatinine <2.0 times upper normal limit (unless normal creatinine clearance).
- •Total bilirubin <2.0 times upper normal limit (unless due to Gilbert's syndrome).
- •Alanine aminotransferase (ALT) <3.0 times upper normal limit
- •8)Able to take oral medication
- •9)Progression during or after platinum-based chemotherapy
- •10)Other prior chemotherapy apart from first-line treatment for pancreatic cancer, are allowed, including maintenance treatment with PARP inhibitors
- •11) More than 2 weeks since prior chemotherapy end
- •12) Signed written informed consent
- •13) QTc <450 msec or QTc <480 msec for patients with bundle branch block
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1)Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities
- •2)Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- •3)Vaccination with vaccines called live”, since this treatment causes a drop of immunity defenses and a serious infection could result fatal.
- •4)History of seizure, head trauma and treatment with anti-epileptogenic drugs
- •5)Hypersensitivity to chlorambucil or to any excipients, in particular lactose
- •6)BRCA-mutated advanced pancreatic cancer who did not undergo maintenance with olaparib after platinum-based chemotherapy
- •7)Mismatch repair (MMR)/high levels of microsatellite instability (MSI-H), or high levels of tumor mutational burden (TMB) pancreatic cancer who did not undergo immunotherapy with pembrolizumab monotherapy or any other anti-PD1 agent
- •8)Concomitant PARP inhibitors therapy
- •9)Life expectancy less than 3 months, in the opinion of the investigator
- •10)Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible
- •11)Symptomatic duodenal stenosis
- •12) Any significant medical condition laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
- •13) Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- •14) Any condition that confounds the ability to interpret data from the study
- •15) Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up
- •16) Pregnant or nursing. Adequate contraception is defined as oral hormonal birth control, intrauterine device, and male partner sterilization
- •17) Concurrent treatment with other experimental drugs
研究者
相似试验
进行中（未招募）
2 期
Chlorambucil in Metastatic PDAC Patients Bearing a Germ Line DNA Defects Repair Mutations (SALE Trial)Pancreatic Ductal AdenocarcinomaNCT04692740Michele Reni20
招募中
2 期
THIS IS A CLINICAL STUDY WHICH EVALUATES TREATMENT WITH CHLORAMBUCIL AND RITUXIMAB FOLLOWED BY RITUXIMAB GIVEN UNDER THE SKIN IN PATIENTS WITH A TYPE OF LYMPHOMA CALLED MALT LYMPHOMA2023-507291-52-00Association International Extranodal Lymphoma Study Group (IELSG)106
进行中（未招募）
不适用
A study of chlorambucil plus MabThera as induction therapy followed in responders by maintenance therapy versus observation on response rate in patients ≥ 60 years with previously untreated chronic lymphocytic leukemia - NDEUCTR2008-001612-20-ITROCHE
进行中（未招募）
1 期
A phase II study of bethanechol chloride to treat pseudomembranous candidosis in cancer patients with salivary gland dysfunction. - BOC studyEUCTR2006-004282-34-GBRoyal Marsden NHS Foundation Trust
进行中（未招募）
2 期
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT LymphomaMALT LymphomaNCT01808599International Extranodal Lymphoma Study Group (IELSG)112