EUCTR2016-000558-37-IT进行中（未招募）1 期
A Phase 1/2 Study of ARQ 092 in Patients with Overgrowth Diseases and Vascular Anomalies with Genetic Alterations of the PI3K/AKT Pathway - ARQ 092-103
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ArQule, Inc.
- 入组人数
- 16
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
入选标准
- •Each prospective subject must meet ALL of the following inclusion criteria in order to be eligible for this study:
- •1. Male or female subjects = 6 years old
- •2. Overgrowth diseases or vascular anomalies with documented and/or confirmed somatic genetic alterations of PIK3CA, AKT, or PTEN defined/assessed as:
- •? Measureable segmental overgrowth, currently experiencing growth, or with clinical history of overgrowth progression
- •? Vascular and/or lymphatic overgrowth diseases as determined by clinical (such as dermatological), imaging (e.g., bi-dimensional/volumetric MRI, CT, ultrasound), and histological/cytological criteria
- •3. Subjects with significant morbidity, poor quality of life, or with disease characterized by poor prognosis
- •4. No standard systemic therapeutic option available or no satisfactory response to prior experimental or local therapies
- •5. Signed informed consent and, when applicable, signed assent
- •6. Hemoglobin (Hgb) depending on age:
- •? 6-9 years male and female: = 11.5 g/dL
- •? 10-17 years female: = 12.0 g/dL
- •? 10-17 years male: = 12.5 g/dL
- •? > 17 years male and female: = 10.0 g/dL
- •7. Absolute neutrophil count (ANC): = 1.5 x 109/L
- •8. Platelet count = 150 x 109/L (for subjects with KHE or MLT, platelet count must be = 75 x 109/L)
- •9. Total bilirubin = 1.5 x upper limit of normal (ULN)/L
- •10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3 x ULN
- •11. Serum creatinine depending on age:
- •? 6-10 years male and female: maximum 0.59 mg/dL
- •? 11-15 years male and female: maximum 1.2 mg/dL
- •? > 15 years male and female: maximum 1.5 mg/dL
- •12. If a female is of child-bearing potential, documentation of a negative pregnancy test is required prior to enrollment. Sexually active subjects (male and female) must use adequate contraceptive measures while on study and for up to 90 days after ending treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Potential subjects who meet ANY of the following exclusion criteria are not eligible for enrollment into this study:
- •1. History of Type 1 or 2 uncontrolled diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose = 160 mg/dL (if > 12 years) and = 180 mg/dL (if = 12 years) at the screening visit
- •2. Grade = 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version 4.03]) hypercholesterolemia or hypertriglyceridemia or > 8% glycated Hgb (HbA1C)
- •3. Malabsorption syndrome
- •4. History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 092 (MI occurring > 6 months of the first dose of ARQ 092 will be permitted); Grade 2 (per NCI CTCAE version 4.03) or worse conduction defect (e.g., right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/multigated acquisition (MUGA) scan
- •5. Major surgery, chemotherapy, radiotherapy, or immunotherapy within four weeks of the first dose of ARQ 092
- •6. No experimental systemic therapy for the purpose of treating PIK3CA Related Overgrowth Spectrum (PROS) (e.g., sirolimus, everolimus, high dose steroids) within two weeks of first dose of ARQ 092
- •7. Previous treatment with AKT inhibitors
- •8. Concurrent severe uncontrolled illness not related to overgrowth diseases
- •9. Ongoing or active known infection, including human immunodeficiency virus (HIV) infection or bleeding
- •10. Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements
- •11. Pregnant or breastfeeding
- •12. Severe hypersensitivity reactions to mTOR inhibitors (e.g., sirolimus, everolimus)
- •13. Insufficient language proficiency of the subject (or legal guardian) to complete the informed consent and quality of life questionnaires
- •14. Inability to swallow oral medications
研究者
相似试验
进行中（未招募）
不适用
A Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Associated TumorsEUCTR2009-011669-10-GBArQule, Inc.39
进行中（未招募）
不适用
A Phase 2 Study of ARQ 501 in Patients with Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckEUCTR2006-001942-15-DEARQule Inc.60
进行中（未招募）
1 期
A Phase 1/2 Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors with FGFR Genetic AlterationsAdvanced Solid Tumors with FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma with FGFR2 Gene FusionMedDRA version: 20.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10073077Term: Intrahepatic cholangiocarcinomaSystem Organ Class: 100000004864EUCTR2015-001443-36-ITARQULE INC120
进行中（未招募）
1 期
A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects with PIK3CA-related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS)PIK3CA-related overgrowth spectrum (PROS) and Proteus syndrome (PS).MedDRA version: 20.0Level: LLTClassification code 10018058Term: Gene genetic abnormalitySystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10069758Term: Somatic mutationSystem Organ Class: 100000004867EUCTR2016-000558-37-ESArQule, Inc.65
进行中（未招募）
1 期
A Phase 1/2 Study of ARQ 092 (Miransertib) in Subjects with PIK3CA-related Overgrowth Spectrum (PROS) and Proteus Syndrome (PS)EUCTR2016-000558-37-GBArQule, Inc.65