EUCTR2007-005299-15-GB进行中（未招募）不适用
A Phase I/IIa Open-label Dose Escalation Study to Assess the Safety, Tolerability and Preliminary Efficacy of AT9283 in Patients with Intermediate or High-Risk Myelofibrosis.
Astex Therapeutics Ltd0 个研究点开始时间: 2007年11月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Provision of signed written informed consent.
- •Age 18 years or older.
- •Histological evidence of myelofibrosis from a bone marrow biopsy (either primary or following previous treatment of polycythemia vera or essential thrombocythemia).
- •Patients with intermediate or high risk myelofibrosis (according to Blood Vol 88 No 3 (1996) p1013-1018), who have received prior treatment with at least one therapy which has been discontinued either as a consequence of toxicity or unsatisfactory efficacy.
- •ECOG performance status 0, 1 or 2.
- •Negative serum or urine pregnancy test or evidence of surgical sterility or evidence of post-menopausal status. Post-menopausal status is defined as any of the following: natural menopause with menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Be pregnant or lactating (women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrolment). Male and female patients of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient’s medical records).
- •Inadequate liver function as demonstrated by serum bilirubin > 2.5 times the upper limits of reference range (ULRR) (unless due to Gilbert’s syndrome) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or alkaline phosphatase (ALP) = 2.5 times the ULRR.
- •The presence of a bcr-abl fusion product in bone marrow or peripheral blood.
- •Significant renal impairment defined as serum creatinine > 1.5 ULRR.
- •All previous therapies for myelofibrosis must have been completed at least one month prior to treatment with AT9283 (other than supportive therapies such as antibiotics or blood product transfusions).
- •Prior treatment with a JAK2 inhibitor.
- •Incomplete recovery from surgery or radiotherapy other than stable < Grade 2 toxicity.
- •History of an ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months of study entry.
- •Previous malignancy, except for non-basal-cell carcinoma of skin or carcinoma-in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.
- •Any evidence of severe or uncontrolled systemic conditions (e.g., systemic infection) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- •Prior history of infection with human immunodeficiency virus (HIV), known active hepatitis B or C viruses – screening for viral infections is not required for entry to this study.
- •Epilepsy or other convulsive disorder requiring active management.
研究者
相似试验
尚未招募
2 期
A Phase I/II Open-Label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects with NUT Midline Carcinoma (NMC) and Other Cancers (BET115521)NUT Midline Carcinoma and other solid tumors10027655NL-OMON43804GlaxoSmithKline10
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerT Midline Carcinoma and other solid tumorsMedDRA version: 18.0Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864EUCTR2014-004982-25-FRGlaxoSmithKline Research and Development Ltd196
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in subjects with hematologic malignanciesPatients with relapsed and/or refractory haematological malignancies (lymphoma, leukemia, or multiple myeloma)MedDRA version: 19.0Level: LLTClassification code 10066481Term: Hematological malignancySystem Organ Class: 100000004864EUCTR2013-000445-39-ESGlaxoSmithKline, S.A.111
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerEUCTR2014-004982-25-NLGlaxoSmithKline Research and Development Ltd196
进行中（未招募）
1 期
Clinical study using the drug GSK525762 in Subjects with cancerT Midline Carcinoma and other solid tumors.MedDRA version: 18.0 Level: LLT Classification code 10007284 Term: Carcinoma System Organ Class: 100000004864EUCTR2014-004982-25-ESGlaxoSmithKline, S.A.196