EUCTR2013-004009-25-GB进行中（未招募）1 期
A Phase I/II, Dose Escalation Study to Assess the Safety and Tolerability of VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours - Dose finding safety study of VAL201 in cancer patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ValiRx plc
- 入组人数
- 81
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
- •(i) Specific Inclusion Criteria for Patients with Prostate Cancer
- •1. Patients with incurable, locally advanced or metastatic prostate cancer who have relapsed following radiotherapy treatment, are in ‘watchful waiting’ or where a policy of intermittent hormone therapy has been decided. These patients must also have the following:
- •a. rising PSA on three samples; each over 2 weeks apart, with the values being greater than 2 ng/mL higher than and at least 25% over the nadir.
- •b. absent or very mild prostate cancer-related symptoms
- •c. no plans for any therapy for prostate cancer in the next two months.
- •2. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of = 1
- •3. Age =18 years at time of consent.
- •(ii) Specific Inclusion Criteria for Patients with Other Advanced Solid Tumours
- •4. Patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available and a rationale for use of VAL201 exists e.g. fibrosarcoma, ovarian cancer.
- •5. Eastern Collaborative Oncology Group (ECOG) Performance Status (PS) of = 2
- •6. Age = 16 years at time of consent.
- •(iii) General Inclusion Criteria for all Patients
- •7. Evaluable disease, either measurable on imaging, or with informative tumour marker(s), as assessed by the PCWG2, or other relevant response assessment criteria for tumour type e.g. RECIST 1.1.
- •8. Recovery to baseline or CTCAE = grade 1, as determined by CTCAE v4.03 criteria, of reversible toxicities related to prior treatment, with the exception of alopecia, lymphopenia, other non-clinically significant adverse events, including those considered related to androgen deprivation therapy.
- •8. Laboratory values at Screening:
- •Absolute neutrophil count =1.5 x 10x9/L;
- •Platelets =100 x 10x9/L;
- •Haemoglobin =90 g/L without blood transfusion or colony stimulating factor support;
- •Total bilirubin <1.5 times the upper limit of normal,(excluding patients with Gilberts Disease);;
- •AST (SGOT) =2.5 times the upper limit of normal;
- •ALT (SGPT) =2.5 times the upper limit of normal; =5 x ULN for patients with advanced solid tumours with liver metastases;
- •Serum creatinine = 1.5 x ULN or estimated glomerular filtration rate (GFR) of > 50 mL/min based on the Cockcroft-Gault formula
- •9. Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women = 50 years of age or history of amenorrhea for = 12 months prior to study entry). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 1 month after final administration of VAL201. Note that female patients may be surgically sterile (with appropriate documentation in the patient’s medical records).
- •10. Ability to give written, informed consent prior to any study-specific Screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
- •11. Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>
排除标准
- •(i) Specific Exclusion Criteria for Patients with Prostate Cancer
- •Patients has received:
- •1. an anti-cancer therapy, including investigational agents, within 6 weeks of Cycle 1, Day 1;
- •2. Patients who have undergone prior orchidectomy.
- •(ii) Specific Exclusion Criteria for Patients with Other Advanced Solid Tumours
- •3. Patients has received:
- •a) any chemotherapy regimens (including investigational agents) with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of Cycle 1, Day 1, or received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of Cycle 1, Day 1.
- •b) radiotherapy, immunotherapy or biological agents (includes investigational agents) within 4 weeks of Cycle 1, Day 1. Localised palliative radiotherapy is permitted for symptom control.
- •4. Pregnant or lactating female patients.
- •(iii) General Exclusion Criteria for all Patients
- •5. Documented, symptomatic or uncontrolled brain metastases.
- •6. History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of Cycle 1, Day 1.
- •7. Known human immunodeficiency virus positivity.
- •8. Active hepatitis B or C or other active liver disease (other than malignancy).
- •9. Any active, clinically significant, viral, bacterial, or systemic fungal infection within 4 weeks prior to Cycle 1, Day 1.
- •10. Any medical history that in the Investigator's opinion would jeopardize compliance with the protocol.
研究者
相似试验
招募中
1 期
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-C3 in Adult Healthy Volunteers and in Adult Patients With Complement-Mediated Renal Diseasecomplement-mediated renal diseaseMedDRA version: 23.0Level: PTClassification code: 10083522Term: Immune-mediated renal disorder Class: 100000004857CTIS2023-506690-36-00Arrowhead Pharmaceuticals Inc.69
进行中（未招募）
1 期
Study of ARO-DUX4 in Adult Patients With Facioscapulohumeral Muscular Dystrophy Type 1CTIS2023-509748-89-00Arrowhead Pharmaceuticals Inc.70
已完成
不适用
A Phase 1, Dose Escalation Study to Evaluate the safety tolerability and pharmacokinetics of single oral doses of ELND007 in healthy elderly subjects.dementiaAlzheimerNL-OMON34459Elan Pharma42
进行中（未招募）
1 期
A clinical gene therapy study with hematopoietic stem cells for the treatment of patients suffering from a malignant neoplasm of the central nervous systemGlioblastoma MultiformeEUCTR2018-001404-11-ITGENENTA SCIENCE SR21
进行中（未招募）
1 期
A phase 1/2 study in which, DTX-SPL8783, the trial medication will beadministered (alone or in combination with nintedanib) in order to assess the safety, tolerability, pharmacokinetics (distribution of DTX-SPL8783 in the body) and efficacy in patients with advanced malignant tumours.ocally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC).MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864EUCTR2016-000877-19-GBStarpharma Pty Ltd.65