EUCTR2017-001554-33-NL进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •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.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
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.
- •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 PATIENTS IN Arm 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.
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