ACTRN12621000093886终止2 期
A Phase 2, open label, multicentre study assessing the safety and efficacy of ACT001 in combination with whole brain radiation therapy (WBRT) for brain metastases from solid tumours.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patients with secondary brain metastases from solid tumours including NSCLC, breast, urogenital, head and neck, hepatocellular, melanoma and colorectal cancers. Definitive diagnosis of the primary site tumour by histology/cytology or molecular pathology;
- •2. Participants that are assessed by the investigator to be suitable for WBRT;
- •3. At least 1 measurable lesion according to RANO-BM criteria (verified by the radiologist and clinician), with a diameter of the lesion should be >/=10mm < /=40 mm;
- •4. No previous history of abnormal bleeding and coagulation function International Normalised Ratio (INR) < /= 2;
- •5. Age >/= 18 years
- •6. Normal organ function (Absolute Neutrophil Count (ANC) >/=1.5 × 109/L, lymphocyte count >/= 0.5×109/L, platelet count >/= 75×109/L, Haemoglobin (Hb) >/= 10 g/dl; total Bilirubin < /= 1.5 x upper limit of normal (ULN); Alanine Aminotransferase (ALT) and Aspartate aminotransferase (AST) < /= 2.5 x ULN [if liver metastases are present < /= 5.0 x ULN]; plasma creatinine < /= 1.5 x ULN; QTc < 450 ms [males], < 470 ms [females];
- •7. Life expectancy of at least 6 months
- •8. Female participants must also fulfill the following criteria before enrolment can be considered: • Of non-childbearing potential, defined as:
- •Previous hysterectomy or bilateral oophorectomy,
- •or Previous bilateral tubal ligation,
- •or Menopause (total cessation of menses for >/= 1 year).
- •Of childbearing potential, but serum pregnancy test was negative during screening (within 7 days prior to the first dose of the investigational drug.) and agrees to employ contraceptive measures (such as intrauterine device, contraceptive drugs, or condoms) that are medically recognized before enrolment and during the study until 30 days after the last dose of the investigational drug.
- •9. Male patients who are sexually active must agree to employ barrier contraceptive measures or complete abstinence.
- •10. Agrees to sign the informed consent form before study enrolment.
排除标准
- •1. Past history of brain radiotherapy.
- •2. Participants with uncontrollable infection (systemic infection within 4 weeks prior to enrolment).
- •3. Suffered from malignancies other than the primary tumour within 5 years prior to screening (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, and ductal carcinoma in situ).
- •4. Participants previously diagnosed with small cell lung carcinoma (SCLC) with brain metastases
- •5. Participants requiring continuous administration of hematopoietic factors (including granulocyte colony-stimulating factor, macrophage colony-stimulating factor) or platelet transfusion to maintain platelet count and absolute neutrophil count.
- •6. Participants with severe heart disease before enrolment, such as unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association Class > II) or stroke (except for lacunar infarction).
- •7. Patients with hypertension that cannot be controlled by drugs (systolic blood pressure over or equal to 160 mmHg, diastolic blood pressure over or equal to 100 mmHg after taking anti-hypertensive medications).
- •8. Patients who are unable to take the drug orally or have malabsorption syndrome.
- •9. Presence of epilepsy and/or elevated intracranial pressure that is refractory to drugs.
- •10. Uncontrollable spinal cord compression
- •11. Active cerebral haemorrhage in CT/MRI examinations.
- •12. Known allergy to ACT001 or similar compounds or any component in the ACT001 formulation.
- •13. Patients who received other anti-tumour treatment for brain metastases of solid tumours within 4 weeks prior to ACT001 treatment, such as chemotherapy, biologic therapy or targeted therapy, immunotherapy, radiotherapy, or electric field therapy.
- •14. Toxicity caused by past anti-tumour treatment that has not been resolved, which is defined as: Toxicity that did not resolved to Grade < 2 according to CTCAE V 5.0 criteria (except for alopecia, alkaline phosphatase, and gamma-glutamyl transferase (GGT). Stable toxicity may be allowed after discussion with the investigator and sponsor.
- •15. Pregnant or lactating women.
- •16. Patients who participated in other clinical trials within 4 weeks prior to screening.
- •17. Other reasons that are deemed unsuitable for participation in this trial by the investigator
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate THR-317 the treatment of Macular Telangiectasia Type 1 (MacTel 1)Macular Telangiectasia Type 1 (MacTel 1)MedDRA version: 20.1Level: PTClassification code 10038899Term: Retinal telangiectasiaSystem Organ Class: 10015919 - Eye disordersEUCTR2017-004010-26-FRThromboGenics NV10
进行中（未招募）
1 期
A multi center study to assess the safety and efficacy of nab-paclitaxel with CC-486, nab-paclitaxel with MEDI4736 and nab-paclitaxel alone as 2nd/3rd line treatment in subjects with advanced NSCLCAdvanced non-small cell lung cancer (NSCLC).MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001105-41-DECelgene Corporation240
进行中（未招募）
不适用
The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and AdolescentsCrohn’s DiseaseMedDRA version: 17.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2014-004381-24-Outside-EU/EEACB Celltech100
已完成
2 期
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)ide Analogs in Participants With Chronic Hepatitis B Virus InfectioHepatitis B, ChronicJPRN-jRCT2061210044akama Takahiro102
进行中（未招募）
1 期
A Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.Chronic Hepatitis B Virus InfectionMedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-002450-81-PLJanssen-Cilag International NV102