EUCTR2010-022812-37-GB进行中（未招募）1 期
A phase 2 trial of AZD1152 in relapsed/refractory diffuse large B-cell lymphoma - AZD1152 in diffuse large B-cell lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
入选标准
- •A participant will be eligible for inclusion in this study if all of the following criteria apply:
- •1. Male or Female, aged = 18 years.
- •2. ECOG performance score of 0, 1 or 2.
- •3. Life expectancy of at least 12 weeks.
- •4. Haematological and biochemical indices within the ranges shown below.
- •Lab Test Value required
- •Haemoglobin (Hb) = 9g/dL
- •White Blood Count (WBC) = 2x10^9/L
- •Platelet count = 100x10^9/L
- •Absolute Neutrophil count = 1.0x10^9/L
- •Serum bilirubin = 1.5 x ULN
- •AST (SGOT) or ALT = 2.5 x ULN
- •Creatinine clearance (Cockcroft-Gault)> 50 ml/min
- •5. Relapsed or refractory DLBCL in which all participants must have received at least one potentially curative established immunochemotherapy lymphoma regimen that contained rituximab (e.g. R-CHOP, R-PMitCEBO, R-GCVP, R-CNOP). Participants must also have failed or be ineligible for salvage/high dose therapy.
- •6. Relapsed or refractory DLBCL proven by biopsy (within 6 months of enrollment in trial); either de novo DLBCL or transformed low grade lymphoma.
- •7. At least 1 lesion (> 1.5cm), not previously irradiated, that can be accurately measured on CT and which is FDG avid on PET-CT scanning, as defined by Cheson criteria.
- •8. Able to give an informed consent and be capable of co-operating with the protocol.
- •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 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •A participant will not be eligible for the trial if any of the following apply:
- •1. Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days prior to Day 1. (see protocol for full detail on steroid use).
- •2. Any unresolved toxicity from prior anti-cancer therapy, which is greater than CTCAE grade I (except alopecia).
- •3. Previous treatment with aurora kinase inhibitors.
- •4. Clinical evidence of central nervous system involvement.
- •5. Another active malignancy within the past five years, except adequately treated basal or squamous cell carcinoma of the skin, or carcinoma of the cervix in situ.
- •6. Clinically significant and uncontrolled major medical condition(s) including but not limited to: active infection, bleeding diathesis, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations which would limit compliance with protocol requirements.
- •7. Major surgery within 4 weeks prior to entry into the study (excluding placement of vascular access or biopsy) that involved general anaesthesia or respiratory assistance.
- •8. Mean QTc interval = 470 ms calculated from 3 ECGs using Fridericia’s or Bazett’s correction.
- •9. Serologically positive for HIV, hepatitis B or C assessed within 28 days of initiation of study treatment.
- •10. Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants).
- •11. Pregnant or breastfeeding women. Female participants must have a negative urinary or serum pregnancy test when done or have evidence of post-menopausal status (Defined as absence of menstruation for greater than 12 months, bilateral oophorectomy or hysterectomy).
- •12.Participants who have had live attenuated or yellow fever vaccines within 6 months of trial beginning.
- •13. Participants not willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
研究者
相似试验
已完成
不适用
Phase II Study of AZD9291 in patients with advanced stage non-small cell lung cancer following prior EGFR TKI Therapy with EGFR and T790M mutations detected in plasma circulating tumor DNA (PLASMA)NeoplasmsKCT0003197ational University Cancer Institute108
已完成
2 期
AZD2171 in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic LeukemiaB-cell Chronic Lymphocytic LeukemiaRefractory Chronic Lymphocytic LeukemiaNCT00321724National Cancer Institute (NCI)35
已完成
2 期
AZD2171 in Treating Patients With Recurrent or Stage IV MelanomaAcral Lentiginous Malignant MelanomaCiliary Body and Choroid Melanoma, Medium/Large SizeCiliary Body and Choroid Melanoma, Small SizeExtraocular Extension MelanomaIntraocular MelanomaLentigo Maligna Malignant MelanomaRecurrent MelanomaStage, Intraocular MelanomaStage IV MelanomaSuperficial Spreading Malignant MelanomaIris MelanomaNCT00243061National Cancer Institute (NCI)24
已完成
2 期
Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) PatientsAcute Myeloid LeukemiaNCT00952588AstraZeneca74
进行中（未招募）
1 期
A PHASE II TRIAL OF LONG-TERM TREATMENT WITH AZITHROMYCIN IN PATIENTS WITH LYMPHOMA OF THE MUCOSA ASSOCIATED LYMPHOID TISSUE (MALT) LYMPHOMAEUCTR2016-001521-13-ATMed. Univ. Wien16