EUCTR2014-001240-38-GB进行中（未招募）1 期
A Phase 2 Study of the Safety and Anti-tumor Activity of the Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients with Refractory and/or Relapsed Richter’s Transformation (RT). - SIRRT (Selinexor in Relapsed/Refractory Richters Transformation)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •- male and female patients aged 18 years or older
- •- willing to sign a written informed consent document
- •- possess a histologically confirmed diagnosis of DLBCL
- •- All patients deemed fit for standard chemo-immunotherapy must have received at least one, and no more than two, prior regimens for RT including cytotoxic chemotherapy and anti-CD20 monoclonal antibodies. Patients who are currently deemed unfit for standard cytotoxic chemotherapy must have received one prior therapy, including an anti-CD20 monoclonal antibody therapy.
- •- One or more measurable (> 1.5 cm in longest dimension) disease sites
- •- Objective documented evidence of disease progression at study entry
- •- Eastern Cooperative Oncology Group (ECOG) performance status of = 2
- •- Baseline platelet count = 30,000/mm3 and absolute neutrophil count = 500/mm3
- •- Patients who are hepatitis B PCR negative who have a recent (< 6 month) history of IVIG therapy
- •- Adequate hepatic function: bilirubin = 2 times the upper limit of normal (ULN) and AST and ALT < 2.5 times ULN
- •- Adequate renal function
- •- For both male and female patients, effective methods of contraception must be used throughout the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Patients who are pregnant or lactating
- •- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy = 2 weeks prior to Cycle 1 Day 1
- •- Less than 1 month since completion of autologous stem cell transplantation or less than 3 months since completion of allogeneic stem cell transplantation
- •- Major surgery within four weeks of Cycle 1 Day 1
- •- Unstable cardiovascular function
- •- Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose.
- •- Presence of central nervous system (CNS) leukaemia or lymphoma.
- •- Known active hepatitis B virus (HBV) or C virus (HCV) infection
- •- Impairment of gastrointestinal (GI) function or GI disease that could interfere with the absorption of selinexor
- •- Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant
- •- Serious psychiatric or medical conditions that could interfere with treatment.
- •- Participation in an investigational anti-cancer study within 2 weeks prior to Cycle 1 Day 1.
- •- Concurrent therapy with approved or investigational anticancer therapeutic
研究者
相似试验
进行中（未招募）
1 期
Richters TransformatioInitial and Refractory/Relapsed Richters Transformation (RT)MedDRA version: 18.0Level: PTClassification code 10058728Term: Richter's syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001240-38-DEKaryopharm Therapeutics, Inc.50
进行中（未招募）
1 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864EUCTR2018-000345-39-NLPfizer Inc., 235 East 42nd Street, New York, NY 10017541
已完成
2 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant TumorsNL-OMON48840Pfizer22
进行中（未招募）
1 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2018-000345-39-FRPfizer Inc., 235 East 42nd Street, New York, NY 10017541
进行中（未招募）
1 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant TumorsEUCTR2018-000345-39-ITPFIZER INC541