EUCTR2020-004870-22-NL进行中（未招募）1 期
A Phase 2, Adaptive, Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Intravenous AMB-05X in Subjects with Tenosynovial Giant Cell Tumor
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •1. Male or female =18 years of age.
- •2. Able to communicate well with study staff, understand and comply with
- •the requirements of the study, and read and voluntarily sign the informed
- •consent form (ICF) and the Health Insurance Portability and
- •Accountability Act (HIPAA) authorization (if applicable) before the
- •conduct of any study-specific procedures.
- •3. TGCT that meets both of the following criteria:
- •a. Diagnosis has been histologically confirmed by a pathologist. If the
- •diagnosis has not been previously histologically confirmed, biopsy
- •with histological confirmation is required before enrollment.
- •b. Has not been surgically resected either because surgical resection
- •would be associated with potentially worsening functional limitation
- •/ severe morbidity (locally advanced disease) or because the subject
- •declined surgery.
- •4. Measurable disease as defined by RECIST v1.1 (except with a minimum
- •size of 2 cm), assessed from MRI scans by a central radiologist.
- •5. Symptomatic disease defined as one or both of the following:
- •a. A score of at least 4 on the Worst Pain NRS at Screening.
- •b. A score of at least 4 on the Worst Stiffness NRS at Screening.
- •6. Stable prescription of analgesic regimen during the 2 weeks before
- •7. Women of childbearing potential must have a negative serum pregnancy
- •test at Screening and a negative urine pregnancy test at Baseline.
- •8. Agrees to follow contraception guidelines (see Section 5.3).
- •9. Adequate hematologic, hepatic, and renal function at Screening, defined
- •Absolute neutrophil count = 1.5 × 109/L
- •Aspartate aminotransferase (AST) and alanine aminotransferase
- •(ALT) = 1.5 × upper limit of normal (ULN)
- •Hemoglobin > 10 g/dL
- •Total bilirubin = 1.5 × ULN
- •Platelet count = 100 × 109/L
- •Serum creatinine = 1.5 × ULN
- •10. Willing and able to complete the PROMIS Physical Function Scale,
- •Worst Stiffness NRS, BPI, and EQ-5D-5L throughout the study.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Use of any investigational drug within 4 weeks or 5 half-lives (whichever
- •is longer) before Baseline.
- •2. Any previous use of pexidartinib or any biologic treatment targeting
- •CSF1 or CSF1R. Use of an oral tyrosine kinase inhibitor other than
- •pexidartinib (eg, imatinib or nilotinib) within 3 months before Baseline.
- •3. Active cancer (either currently or within 1 year before Baseline) that
- •requires/required therapy (eg, surgery, chemotherapy, or radiation
- •therapy), with the exception of adequately treated basal or squamous cell
- •carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix
- •or breast, or prostate carcinoma not requiring treatment apart from active
- •surveillance.
- •4. Known metastatic TGCT.
- •5. Hepatitis C virus (HCV) or hepatitis B virus (HBV) or known active or
- •chronic infection with human immunodeficiency virus (HIV).
- •6. Known active tuberculosis (TB).
- •7. Significant concomitant arthropathy in the affected joint, serious illness,
- •uncontrolled infection, or a medical or psychiatric history that, in the
- •Investigator's opinion, would likely interfere with the subject’s study
- •participation or the interpretation of the subject’s results.
- •8. A woman who is breastfeeding.
- •9. A screening Fridericia-corrected QT interval (QTcF) =450 ms (men) or
- •=470 ms (women)
- •10. MRI contraindications (eg, pacemaker, loose metallic implants)
- •11. History of hypersensitivity to any ingredient in the study drug.
- •12. History of drug or alcohol abuse within 3 months before Baseline.
- •13. Has any other severe acute or chronic medical or psychiatric condition or
- •clinically significant laboratory abnormality that may increase the risk
- •associated with study participation/treatment, interfere with interpretation
- •of study results, or, in the Investigator’s opinion, make the subject
- •inappropriate for this study.
- •14. A subject who, in the opinion of the Investigator, should not participate
- •in this study for any reason, including instances where the subject’s
- •stability or ability to comply with study requirements is in question.
研究者
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