ACTRN12612000779875撤回1 期
A Multicenter, Phase I/II dose escalation study to evaluate the toxicity of once weekly Panobinostat combined with Bortezomib, Cyclophosphamide and Dexamethasone in Treatment Naive Myeloma patients
orth Shore Haematology Clinical Trial Unit0 个研究点目标入组 37 人开始时间: 2012年7月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 37
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
- •Subjects must meet all of the following inclusion criteria to be eligible for the study.
- •1.Patient has a diagnosis of multiple myeloma, based on IMWG 2003 definitions all three of the following criteria had been met:
- •a.Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma cell for non secretory myeloma) .
- •b.Bone marrow (clonal) plasma cells equal to or greater than 10% or biopsy proven plasmacytoma
- •c.Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)
- •2.Patient has measurable disease at study screening defined by at least one of the following measurements as per IMWG 2003 criteria (Kyle, et al 2003):
- •a.Serum M-protein equal to or greater than 1 g/dL or 10 g/L
- •b.Urine M-protein equal to or greater than 200 mg/24 h
- •3.Patients myeloma is treatment naive with the exception of:
- •a. less than two weeks of steroid therapy
- •b.the patient has been treated with local radiotherapy with or without concomitant exposure to steroids for pain control or management of cord/nerve root compression, is eligible. Two weeks must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patient who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and 2 weeks have passed since the last date of therapy
- •4.Patient’s must be at least 18 years old at time of signing the informed consent
- •5.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) equal to or less than 2
- •6.Patient has the following laboratory values within 3 weeks before starting study drug (lab tests may be repeated, as clinically indicated, to obtain acceptable values before failure at screening is concluded but supportive therapies are not to be administered within the week prior to screening tests for ANC or platelet count)
- •a.Absolute neutrophil count (ANC) equal to or greater than 1.5 x 109 /L
- •b.Platelet count equal to or greater than 100 x 109 /L
- •c.Serum potassium, magnesium, phosphorus , within normal limits (WNL) for institution.
- •d.Total calcium (corrected for serum albumin) or ionized calcium greater or equal to lower normal limits (greater than LLN) for institution, and not higher than CTCAE grade 1 in case of elevated value.
- •Note: Potassium, calcium, magnesium, and/or phosphorus supplements may be given to correct values that are less than LLN.
- •e.AST and ALT equal to or less than 2.5 x ULN
- •f.Serum total bilirubin equal to or less than 1.5 ULN (or equal to or less than 3.0 x ULN if patient has Gilbert syndrome)
- •g.Calculated creatinine clearance equal to or greater than 40 ml/min
- •7.Patient has provided written informed consent prior to any screening procedures
- •8.Patient is able to swallow capsules
- •9.Patient must be able to adhere to the study visit schedule and other protocol requirements
- •10.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at baseline
排除标准
- •Exclusion criteria
- •1.Patient has shown intolerance to dexamethasone or cyclophosphamide or components of these drugs
- •2.Patient has greater than 2 grade peripheral neuropathy or grade 1 peripheral neuropathy with pain on clinical examination within 14 days before randomization
- •3.Patient needing valproic acid for any medical condition during the study or within 5 days prior to first administration of panobinostat/study treatment.
- •4.Patient taking any anti-cancer therapy concomitantly (bisphosphonates are permitted)
- •5.Patient has secondary primary malignancy less than 3 years before first dose of study treatment (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix).
- •6.Patient who received prior anti-myeloma chemotherapy or medication including IMiDs prior to start of study.
- •7.Patient who received experimental therapy or biologic immunotherapy including monoclonal antibodies less than 4 weeks prior to start of study.
- •8.Prior radiation therapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior start of study or the patient has not recovered from all therapy-related toxicities associated with radiation treatments to < grade 2 CTCAE.
- •9.Patient has undergone major surgery less than 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy to < grade 2 CTCAE
- •10.Patients with evidence of mucosal or internal bleeding
- •11.Patient has unresolved diarrhea less than CTCAE grade 2
- •12.Patient has impaired cardiac function, including any one of the following:
- •a.LVEF < LLN of institutional norm, as determined by ECHO
- •b.obligate use of a permanent cardiac pacemaker
- •c.congenital long QT syndrome
- •d.history or presence of ventricular tachy-arrhythmias
- •e.resting bradycardia defined as < 50 beats per minute
- •f.QTcF > 450 msec on screening ECG
- •g.complete left bundle branch block (LBBB), bifascicular block
- •h.any clinically significant ST segment and/or T-wave abnormalities
- •i.presence of unstable atrial fibrillation (ventricular response rate > 100 bpm). Patients with stable atrial fibrillation can be enrolled provided they do not meet other cardiac exclusion criteria.
- •j.myocardial infarction or unstable angina pectoris less than 6 months prior to starting study drug
- •k.symptomatic congestive heart failure (New York Heart Association class III-IV)
- •l.other clinically significant heart disease and vascular disease (e.g. uncontrolled hypertension
- •m.Patient taking medications with relative risk of prolonging the QT interval or inducing Torsade de pointes, if such treatment cannot be discontinued or switched to a different medication prior to starting study drug.
- •13.Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat (e.g. ulcerative disease, uncontrolled nausea, vomiting, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
- •14.Patient has any other concurrent severe and/or uncontrolled medical conditions (e.g.,uncontrolled diabetes, active or uncontrolled infection, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause, uncontrolled thyroid dysfunction) that could cause unacceptable safety risks or compromise compliance with the protocol
- •15.Patient has a known history of HIV seropositivity or history of active/treated hepatitis B or C (a test for screening is not required)
- •16.Women who are pregna
研究者
相似试验
已完成
不适用
Simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancerCervical cancerCancerISRCTN76100993Barts and The London NHS Trust (UK)44
招募中
不适用
Multicenter and dose escalation phase 1 study to evaluate the safety and exploratory efficacy of GC1119 (recombinant human a-galactosidase A) for enzyme replacement therapy in Fabry disease patientsCongenital malformations, deformations and chromosomal abnormalitiesKCT0000597Green Cross10
进行中（未招募）
1 期
A multicenter phase I/II dose excalation study of lenalidomide in relapse/refractory Waldenström macroglobulinemiaEUCTR2008-006370-15-FRCHRU de Lille
进行中（未招募）
1 期
A Phase 1/2 clinical trial of the drug Quizartinib (AC220) to investigate the safety and efficacy in paediatric patients (aged 1 month to <18 years) and young adults (aged up to 21 years) with Acute Myeloid Leukemia (AML), a cancer of the blood.Relapsed/Refractory acute myeloid leukemia (AML) in subjects aged =1 month to =21 years with feline McDonough sarcoma-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutations following failure of front-line intensive chemotherapyMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 21.0Level: PTClassification code 10076230Term: Fms-like tyrosine kinase 3 positiveSystem Organ Class: 10022891 - InvestigationsEUCTR2016-002919-18-SEDaiichi Sankyo, Inc.65
进行中（未招募）
1 期
A Phase 1/2 clinical trial of the drug Quizartinib (AC220) to investigate the safety and efficacy in paediatric patients (aged 1 month to <18 years) and young adults (aged up to 21 years) with Acute Myeloid Leukemia (AML), a cancer of the blood.Relapsed/Refractory acute myeloid leukemia (AML) in subjects aged =1 month to =21 years with FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) mutations following failure of front-line intensive chemotherapyMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 21.0Level: PTClassification code 10076230Term: Fms-like tyrosine kinase 3 positiveSystem Organ Class: 10022891 - InvestigationsEUCTR2016-002919-18-BEDaiichi Sankyo, Inc.65