NCT03132155终止2 期
A Phase 2 Study of AMG 337 in Subjects With Advanced or Metastatic Clear Cell Sarcoma That Contains the Ewing Sarcoma Breakpoint Region 1-activating Transcription Factor-1 (EWSR1-ATF1) Gene Fusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a phase 2 study that will assess the efficacy of AMG 337 in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion.
详细描述
The phase 2 single arm study will assess efficacy of AMG 337 (based on confirmed ORR) in subjects with advanced or metastatic clear cell sarcoma that contains the EWSR1-ATF1 gene fusion, as determined by fluorescent in situ hybridization (FISH) or other diagnostic methods and confirmed by RNA sequencing (RNAseq).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- •Able to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Able to self-administer AMG 337 as a whole capsule by mouth every day.
- •Age ≥ 16 years.
- •Histologically confirmed, unresectable, locally advanced or metastatic tumors that contain the EWSR1-ATF1 gene fusion, as determined by fluorescent in situ hybridization (FISH) or other diagnostic methods and confirmed by RNA sequencing (RNAseq).
- •Have measurable disease evaluable in accordance with RECIST Version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Must have a recent Formalin-fixed paraffin-embedded (FFPE) tumor biopsy specimen that was obtained following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period.
- •Must be willing to undergo a biopsy during the treatment period, if considered safe by the investigator.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Hematologic function, as follows:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
- •Platelet count ≥ 50 × 109/L.
- •Hemoglobin > 8 g/dL.
- •Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 × upper limit of normal (ULN), except for subjects on anticoagulation therapy for venous thromboembolism.
- •Renal function, as follows:
- •a. Calculated creatinine clearance > 30 mL/min.
- •Hepatic function, as follows:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN and total bilirubin < 1.5 × ULN.
- •Alkaline phosphatase (ALP) < 2 × ULN (≤ 5 × ULN if bone or liver metastases are present)
- •Agreement to practice effective contraception (both male and female subjects, if the risk of conception exists).
排除标准
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
- •Inability to attend required study visits and return for adequate follow-up, as required for this protocol.
- •Known hypersensitivity to any component of the study medication(s).
- •Women who are nursing, pregnant, or planning to become pregnant during the duration of the study.
- •Current diagnosis or history of a second neoplasm, except the following:
- •a. Adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years.
- •History of bleeding diathesis.
- •Uncontrolled hypertension (systolic > 160 mmHg and/or diastolic > 100 mmHg) or clinically significant cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months before study day 1; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication.
- •Baseline ECG Fridericia's formula QTcF > 470 ms.
- •Active infection requiring intravenous (IV) antibiotics within 2 weeks before study day
- •Significant gastrointestinal disorder (eg, Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that in the opinion of the Investigator may influence drug absorption.
- •Positive result of screening test for human immunodeficiency virus (HIV).
- •Evidence of acute hepatitis B and C. Subjects with chronic hepatitis B or C are eligible if their condition is stable and, in the opinion of the investigator, would not pose a risk to subject safety.
- •Toxicities from prior anti-tumor therapy not resolved to CTCAE Version 4.03 grade 0 or
- •a. Grade 2 toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present or stable for > 4 weeks), such as stable grade 2 peripheral neuropathy or ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria.
- •Participation in this study or in an investigational study and/or procedure with any molecularly targeted agents reported to inhibit Mesenchymal epithelial transition factor (MET) within 14 days before study day
- •Anti-tumor therapy, including chemotherapy, antibody therapy, retinoid therapy, or other investigational therapy within 14 days before study day
- •Therapeutic or palliative radiation therapy within 14 days before study day
- •Major surgery within 28 days before study day
- •Any comorbidity that in the opinion of the investigator may increase the risk of toxicity.
- •Concurrent or prior use of a strong CYP3A4 inhibitor within 14 days before study day 1, including the following: ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
- •Concurrent or prior ingestion of grapefruit or grapefruit products, or other foods known to inhibit CYP3A4 within 7 days before study day
- •Concurrent or prior use of strong CYP3A4 inducers within 28 days before study day 1, including the following: phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, or the herbal supplement St. John's Wort.
研究组 & 干预措施
AMG 337
Experimental
AMG 337 will be administered in patients with advanced or metastatic clear cell sarcoma
干预措施: AMG 337 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 1 year
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
次要结局
- Incidence of Treatment-Emergent Adverse Events (Safety And Tolerability)(1 year)
研究者
研究点 (2)
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