EUCTR2020-005833-34-NL进行中（未招募）1 期
RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients with Progressing Desmoid Tumors - RINGSIDE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
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. 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 controlled with non-opioid medication
- •4. At least 1 measurable lesion amenable to volume measurements by MRI at screening
- •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 immediate significant risk to the subject.
- •6. Agrees to provide FFPE archival or fresh tumor tissue.
- •7. Must be able to swallow whole capsules with no GI condition affecting absorption (not including history of colectomy or proctocolectomy); nasogastric or G-tube administration is not allowed.
- •Gender and Reproductive Considerations
- •8. Male or female subjects.
- •9. Premenstrual female subjects with a history of ovulatory dysfunction may be enrolled
- •10.WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of
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 ischemia
- •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 dose
- •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
- •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 v
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