NL-OMON48745已完成2 期
BGB-290-104: A Phase 1b/2 study to assess the safety, tolerability and efficacy of BGB-290 in combination with radiation therapy and/or temozolomide in subjects with first-line or recurrent/refractory glioblastoma - BGB-290-104
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •ALL PATIENTS
- •1) Age >=18 years old
- •2) Confirmed diagnosis of glioblastoma (WHO Grade IV).
- •3) Ability to undergo serial MRIs.
- •4) ECOG status <= 1.
- •5) Adequate bone marrow function.
- •6) Adequate renal and hepatic function.
- •7) Ability to swallow whole capsules. ;Subjects in Arms A and B (not Arm C) must also meet inclusion criteria:
- •8) No previous treatment for GB except surgery.
- •9) Able to start radiation therapy <= 49 days after surgery but >= 14 days after a biopsy or >=28 days after an open biopsy or craniotomy with adequate wound healing.
- •10) Documented unmethylated MGMT promoter status.;Subjects in Arm C ESCALATION only must also meet inclusion criteria:
- •11) Documentation of MGMT promoter status
- •It is preferable to determine MGMT status by MS-PCR. Other acceptable platforms include pyrosequencing methodologies and MSHRM assays with comparable sensitivity, applied to archival or fresh tumor tissue.
- •12) No prior systemic chemotherapy other than TMZ for GB and nd no prior anti-angiogenic therapy
- •13) Histologically confirmed secondary glioblastoma
- •14) Progressive disease > 2 months after completion of first line therapy.
- •15) Disease that is evaluable or measurable by mRANO ;Subjects in Arm C EXPANSION only must also meet inclusion criteria:
- •16) Histologically confirmed de novo (primary) glioblastoma with unequivocal first progressive disease (PD) after RT with concurrent/adjuvant TMZ chemotherapy as defined by one or more of the following:
- •PD >= 3 months after the end of radiotherapy
- •PD that is clearly outside the radiation field
- •PD that has been unequivocally proven by surgery/biopsy
- •17) Disease that is measurable as defined by RANO criteria
- •18) Documentation of MGMT promoter status.
- •For full list of inclusion criteria refer to the study protocol.
排除标准
- •ALL PATIENTS
- •1) Chemotherapy, biologic therapy, immunotherapy or investigational agent <=21 days (or <=5 half-lives, whichever is shorter) prior to Day 1
- •2) Unresolved acute effects of any prior therapy of Grade >=2, except for AEs not constituting a safety risk by investigator judgement
- •3) Major surgical procedure, open biopsy, or significant traumatic injury <=28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
- •Placement of vascular access device is not considered major surgery.
- •4) Other diagnosis of malignancy
- •Except for surgically excised non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, localized prostate cancer treated with curative intent, adequately treated low-stage bladder cancer, ductal carcinoma in situ treated surgically with curative intent, or a malignancy diagnosed >2 years ago with no current evidence of disease and no therapy <=2 years prior to Day 1
- •5) Active infection requiring systemic treatment
- •6) Active cardiac disease, inflammatory gastrointestinal disease, bleeding disorder (for details see protocol)
- •7) Anticoagulation with heparin, warfarin, or other anticoagulants (for details see protocol)8) Use <=10 days (or <=5 half-lives, whichever is shorter) prior to Day 1 or anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers including known enzyme inducing anti-epileptic drugs;For subjects in Arms B and C (NOT applicable to Arm A)
- •9) Known hypersensitivity to any temozolomide component or to dacarbazine (DTIC)
- •10) Have hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- •For full list of exclusion criteria see protocol.
研究者
相似试验
进行中（未招募）
1 期
A phase Ib/II single-arm study evaluating the safety and efficacy ofcombined immunotherapy with mFOLFOX6, bevacizumab and atezolizumabin advanced-stage biliary canceradvanced biliary tract cancer (BTC)MedDRA version: 27.0Level: PTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000257-45-DEniversity Hospital Essen35
已完成
1 期
An open-label, phase 1b study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of PMX205 in patients with amyotrophic lateral sclerosisMotor Neuron DiseaseParkinson's DiseaseACTRN12622000927729Alsonex Pty Ltd8
进行中（未招募）
1 期
A Study of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA SignalingSolid Tumors Dependent on KIT or PDGFRA SignalingMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2020-005234-15-ITBLUEPRINT MEDICINES CORPORATIO37
进行中（未招募）
1 期
A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA SignalingCTIS2023-508617-16-00Blueprint Medicines Corp.37
进行中（未招募）
1 期
A Study of Avapritinib in Pediatric PatientsSolid Tumors Dependent on KIT or PDGFRA SignalingEUCTR2020-005234-15-DEBlueprint Medicines Corporation37