EUCTR2020-003087-45-DE招募中1 期
An open-label, phase IIa study of the safety, tolerability, pharmacokinetics and pharmacodynamics of oral GB2064 (a LOXL2 inhibitor) in participants with myelofibrosis (The MYLOX-1 study). - The MYLOX-1 study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
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
- 性别
- All
入选标准
- •The main inclusion criteria include a diagnosis of PMF or SMF, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and clinical laboratory parameters within appropriate limits for participants with MF.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Participants are excluded if they are taking or have taken a JAK inhibitor (ruxolitinib or fedratinib) within two weeks of enrolment or chronic (> 14 days) treatment with corticosteroids at a dose up to 60 mg prednisone per day (or its glucocorticoid equivalent) for a maximum of 4 weeks once enrolled in the study, during which the dose should be tapered to =10mg per day, if needed for maintenance, before potentially being discontinued at the Investigators discretion. The dosage of corticosteroids for JAK inhibitor naïve participants should not exceed 10 mg per day should it be necessary while the participant is on the study.
研究者
相似试验
进行中（未招募）
1 期
Study of the safety, tolerability, pharmacokinetics and pharmacodynamics of oral GB2064 in participants with myelofibrosis.Primary (PMF) or secondary (SMF) myelofibrosis.MedDRA version: 20.0Level: PTClassification code 10077161Term: Primary myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-003087-45-ITGalecto Biotech AB24
进行中（未招募）
1 期
A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer.Treatment in patients with HER2-overexpressing locally advanced or metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerEUCTR2008-008276-14-BEF. Hoffmann-la Roche Ltd60
进行中（未招募）
不适用
A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancerTreatment in patients with HER2-overexpressing locally advanced or metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerEUCTR2008-008276-14-DEF. Hoffmann-La Roche Ltd60
进行中（未招募）
1 期
A Phase Ib/II, open-label study of the safety, tolerability, and efficacy of trastuzumab-MCC-DM1 in combination with pertuzumab administered intravenously to patients with HER2-positive locally advanced or metastatic breast cancer who have progressed while receiving prior therapyTreatment in patients with HER2-overexpressing locally advanced or metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerEUCTR2008-008276-14-FRF. Hoffmann-la Roche Ltd40
进行中（未招募）
1 期
A Study to Evaluate the Safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 with Ritonavir and sometimes with Ribavirin in people who have had a Transplant and have Hepatitis C Virus (HCV) infection.Chronic Hepatitis C InfectionMedDRA version: 17.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-004792-39-DEAbbVie Deutschland GmbH & Co. KG175