EUCTR2017-001553-14-GB进行中（未招募）1 期
A Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumors
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
- 250
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 subjects:
- •1.Age =18 years old.
- •2.Confirmed malignancy at advanced or metastatic stage.
- •3.ECOG status = 1.
- •4.Adequate bone marrow function.
- •5.Adequate renal and hepatic function.
- •6. Agree to provide tumor archival tissue
- •Additional inclusion criteria 8 - 12 are specific to tumor types in dose expansion phase:
- •Ovarian cancer:
- •1.Previously received at least 1 line of platinum containing chemotherapy.
- •2.No progression or recurrent disease in 6 months from last platinum containing regimen.
- •Triple-Negative Breast Cancer
- •0 - 1 prior platinum-containing regimen (any treatment setting) and received = 3 prior regimens (advanced or metastatic setting).
- •Metastatic Castration-Resistant Prostate cancer
- •1.Documented progressive disease.
- •2.Chemotherapy-naïve or previously received =2 taxane-based regimens.
- •3.May be pre-or post-treatment with a novel androgen receptor targeted agent.
- •4.Completed in = 2 weeks radiation or treatment with anti-androgen agents.
- •Ovarian, breast and prostate cancer (BRCA+ or HRD+): If homologous recombinant deficiency (HRD) or BRCA status unknown, need pre-screening for eligibility.
- •Extensive Stage Small cell lung and Gastric/Gastroesophageal Junction
- •Cancer cancer: received = 2 prior lines of therapy.
- •HRD+ Solid Tumors. Multiple Indications (Expansion Cohort 6)
- •a. Patient has histologic or cytologic-confirmed advanced (metastatic and/or unresectable)
- •- nonsquamous non-small cell lung cancer (NSCLC)
- •- squamous NSCLC
- •- esophageal cancer
- •- squamous head and neck cancer
- •- soft-tissue sarcomas (undifferentiated pleomorphic sarcoma,leiomyosarcoma, malignant peripheral nerve sheath tumor, dedifferentiated liposarcoma, myxofibrosarcoma)
- •b. Patients must have tumors with homologous recombination deficiency (HRD+) as centrally determined by the Myriad myChoice® HRD Plus assay irrespective of any known molecular signature
- •c. Patients with nonsquamous NSCLC, squamous NSCLC, esophageal cancer and squamous head and neck cancer must have received at least 1 but not more than 3 prior lines of therapy
- •d. Patients with soft tissue sarcoma must have received at least 1 but no more than 3 prior lines of therapy. Treatment naïve patients may be allowed if, in the opinion of the investigator, available standard of care first line therapy is not appropriate
- •Other protocol-defined inclusion criteria may apply (see protocol for details).
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •All subjects
- •1.Prior exposure to a PARP inhibitor.
- •2.Prior chemotherapy, biologic therapy, immunotherapy or investigational agents within 3 weeks prior to start of study treatment.
- •3.Refractory to platinum-based therapy.
- •4. Any unresolved toxicity of = Grade 2 from prior therapy.
- •5.Major surgery or significant injury = 4 weeks prior to start of study treatment.
- •6.History of other active malignancies within 2 years with exception of (i) adequately treated in situ carcinoma of the cervix, (ii) non-melanoma skin cancer, or (iii) localized adequately treated cancer with curative intent or malignancy diagnosed > 2 years ago with no evidence of disease and no treatment = 2 years prior to study treatment.
- •7.Untreated leptomeningeal or brain metastasis.
- •8.Active infection requiring systemic treatment.
- •9.Known human immunodeficiency virus (HIV) or active viral hepatitis.
- •10.Active, clinically significant cardiac disease or any Class 3 or 4 cardiac disease, ventricular arrhythmia or CVA = 6 months prior to start of treatment.
- •11.Active, clinically significant gastrointestinal disease.
- •12.Use of any medications or food known to be strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong inducers.
- •13.Pregnant or nursing females.
- •14. Have hereditary problems of galactose intolerance, the Lapp lactase
- •deficiency, or glucose-galactose malabsorption
研究者
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