EUCTR2020-005833-34-PL招募中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
- 招募中
- 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
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 adolescentsand 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 by investigator.
- •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); 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
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 anti-bacterial, 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
- •15. 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
- •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
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