NL-OMON56437招募中3 期
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors - AL-DES-01
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. At least 18 years of age (inclusive) at the time of signing the ICF.
- •2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local
- •pathologist (prior to informed consent).
- •3. Disease progression, assessed by the investigator, defined as having at
- •least one of the following:
- •a) Unidimensional growth of desmoid tumor(s) by >=10%, using the sum of the
- •largest diameters of target lesion(s), within 18 months of the
- •screening MRI
- •b) Having desmoid tumor-related pain that is not adequately controlledwith
- •non-opioid medication
- •4. At least 1 measurable lesion amenable to volume measurements byMRI at
- •5. One of the following:
- •Treatment naïve subjects for whom, in the opinion of the investigator, the IP
- •is deemed appropriate; OR
- •Recurrent/refractory disease following at least one line of therapy
- •(including surgery, radiation, or systemic therapy).
- •6. A desmoid tumor in which continued progressing disease will not result in
- •immediate significant risk to the subject.
- •7. Agrees to provide formalin-fixed paraffin embedded (FFPE) archival or fresh
- •tumor tissue.
- •8. Must be able to swallow whole capsules with no GI condition affecting
- •absorption (not including history of colectomy); nasogastric or G-tube
- •administration is not allowed.
- •9. Male or female subjects.
- •10. Women of childbearing potential (WOCBP) must have a negative serum or urine
- •pregnancy test (minimum sensitivity 25 IU/L or
- •equivalent units of human chorionic gonadotropin [hCG]) within 24 hours prior
- •to the start of investigational product (IP). An extension up
- •to 72 hours is permissible in situations where results cannot be obtained
- •within the standard 24 hour window.
- •11. WOCBP and men who are sexually active with WOCBP must agree to follow
- •instructions for method(s) of contraception for the duration of the treatment
- •with IP plus 120 days post-treatment completion.
- •Contraception methods should be consistent with local regulations.
- •12. Capable of giving signed informed consent which includes compliance with
- •the requirements and restrictions listed in the ICF and in this protocol.
- •1. >=12 years of age (inclusive) in countries which allow participation of
- •adolescents and >= 40 kg at the time of signing the ICF.
- •2. Histologically confirmed desmoid tumor (aggressive fibromatosis) by local
- •pathologist (prior to informed consent) that has progressed per
- •RECIST v1.1 (>=20% or new lesion) by investigator within 12 months of the
- •screening visit scan.
- •3. Evidence of measurable disease by CT/MRI scan. Measurable lesions are
- •defined according to RECIST v1.1.
- •4. One of the following:
- •Recurrent/refractory disease following at least one line of therapy
- •(including surgery, radiation, or systemic therapy); OR
- •Treatment naïve subjects for whom, in the opinion of the investigator,
- •surgery or radiation therapy is not deemed appropriate;
- •5. A desmoid tumor in which continued progressing disease will not result in
- 另有 7 项未显示
排除标准
- •1. Diagnosed with a malignancy in the past 2 years, unless for protocol defined
- •allowed malignancies
- •2. Current or recent (within 2 months of IP administration) GI disease or
- •disorders that increase the risk of diarrhea, such as inflammatory bowel
- •disease and Crohn's disease
- •3. Evidence of uncontrolled, active infection, requiring systemic
- •antibacterial, anti-viral or anti-fungal therapy <=7 days prior to
- •administration of IP
- •4. Myocardial infarction within 6 months prior to enrollment, greater than
- •Class 1 angina pectoris, or has NYHA Class III or IV heart failure, symptomatic
- •ventricular arrhythmias, sustained ventricular tachycardia, TdP, the long QT
- •syndrome, pacemaker dependence, or electrocardiographic evidence of acute
- •5. History of additional risk factors for TdP
- •6. Unstable or severe uncontrolled medical condition or any important medical
- •illness or abnormal laboratory finding
- •7. Pregnant or breastfeeding or expecting to conceive children during the study
- •8. ECOG performance status >=2
- •9. Abnormal organ and marrow function at Screening defined as: a. Neutrophils
- •<1500/mm3; b. Platelet count <100,000/mm3; c. Hemoglobin <9 g/dL; d.
- •Electrolytes (potassium, calcium, magnesium, and phosphorus, using corrected
- •value if low serum albumin level is
- •present) outside the normal limits of the local laboratory; e. Total bilirubin
- •>1.5x ULN (except known Gilbert's syndrome >3x ULN); f. Aspartate
- •aminotransferase (AST) and alanine aminotransferase (ALT) >2.5x ULN; g. Serum
- •or plasma creatinine > ULN and creatinine clearance (CrCl) <60 mL/min; h.
- •Uncontrolled triglyceride >=Grade 2 elevations per CTCAE v5.0 (>300 mg/dL or
- •>3.42 mmol/L)
- •10. ECG Exclusions : a. Mean QT interval corrected for heart rate using
- •Fridericia's formula (QTcF) >=450 msec; b. QRS duration > 110 ms; c. PR interval
- •> 240 ms; d. Marked ST-T wave abnormalities which would make it difficult to
- •measure the QT interval
- •11. Any treatments for desmoid tumors within 4 weeks prior to first dose
- •12. Chronic NSAIDs for the treatment of desmoid tumors within 4 weeks of first
- •13. Prior treatment with GSI or other agents targeting the Notch pathway
- •14. Use of strong inhibitors of CYP3A4 or strong inducers of CYP3A4
- •18. Contraindication to MRI
- •1. Diagnosed with a malignancy in the past 2 years, unless for protocol defined
- •allowed malignancies
- •2. Current or recent (within 2 months of IP administration) GI disease or
- •disorders that increase the risk of diarrhea, such as inflammatory bowel
- •disease and Crohn's disease
- •3. Evidence of uncontrolled, active infection, requiring systemic
- •antibacterial, anti-viral or anti-fungal therapy <=7 days prior to
- •administration of IP
- •4. Myocardial infarction within 6 months prior to enrollment, greater than
- •Class 1 angina pectoris, or has NYHA Class III or IV heart failure,
- •symptomatic ventricular arrhythmias, sustained ventricular tachycardia, TdP,
- •the long QT syndrome, pacemaker dependence, or electrocardiographic evidence of
- •acute ischemia
- •5. History of additional risk factors for TdP
- 另有 5 项未显示
研究者
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