ACTRN12615001328561尚未招募2 期
Phase II study evaluating the efficacy of Pasireotide LAR (SOM230) dose escalation in patients with refractory non-functional GEP NETs
Peter MacCallum Cancer Centre0 个研究点目标入组 30 人开始时间: 2015年12月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female, over 18 years
- •2. Patients with an histologically documented diagnosis of non-functional WDNET, defined according to the last WHO classification criteria for NET of gastro-entero-pancreatic (WHO/ENET 2010), bronchial and thymic origin (WHO 2004)
- •2. Radiologic disease progression after at least 3 months of octreotide LAR 30mg/28 days
- •3. Measurable/evaluable disease per RECIST Version 1.1,1 (as determined by relevant imaging based on disease site (i.e. for example by multiphase MRI or triphasic CT scan for hepatic metastasis)
- •4. ECOG PS 0-2
- •5. Adequate organ function:
- •Bone marrow: Platelets greater than or equal to 100x10^9/L, Neutrophils greater than or equal to 1.5x10^9/L, Hb greater than or equal to 9g/L
- •Liver: Bilirubin less than or equal to 2.0 xUNL, INR less than or equal to 1.3, AST/ALT less than or equal to 2.5 xUNL (if no hepatic metastases) or AST/ALT less than or equal to 5.0 x UNL (if hepatic metastases).
- •Renal: Serum creatinine less than or equal to 2.0 X ULN
- •6. Females of childbearing potential must provide a negative pregnancy test at the start of the study. Female patients who are at risk of becoming pregnant must agree to use an effective method of contraception. Female patients must agree to use 2 medically acceptable methods of contraception, 1 being an oral contraceptive, dermal patch, or progestin (implantation or injection), and the other being a medically acceptable barrier method; alternatively, 2 medically acceptable barrier methods may be used. Medically acceptable barrier methods of contraception that may be used by the participant and/or his/her partner include: abstinence; diaphragm with spermicide; intrauterine device (IUD); condom together with foam, spermicide, or vaginal spermicidal suppository. Prohibited methods include the rhythm method, withdrawal, condoms alone, or diaphragm alone
- •7. Male patients must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception as described above.
- •8. Informed and written consent as per the Participant Information and Consent Form
- •9. Compliance with trial therapy or trial-related investigations/evaluations by the patient
排除标准
- •1. Patients with intermediate (Grade 2) or high grade (grade 3) NET
- •2. SSA Naive patients
- •3. Patients that have undergone surgery related to NET within 4 weeks prior to study entry or has surgery planned during the study
- •4. Patients that have previously received any specific anti-tumour treatment such as chemotherapy (within the previous 4 weeks), (chemo) embolisation (within the previous 3 months), radiotherapy (within the previous 4 weeks) or interferon (within the previous 4 weeks) or PRRT within the last 6 months.
- •5. Patients that have had a previous cancer (except basal cell carcinoma of the skin, in situ carcinoma of the cervix/uterus, thyroid microcarcinoma, or eradicated thyroid or prostate cancers). Patients with a history of cancer that was not the above mentioned case can be included if they have been treated with curative intent and have been free from disease for more than 3 years.
- •6. Diabetic patients with poor glycemic control as evidenced by HbA1c >8%
- •7. Patients with risk factors for torsades de pointes, i.e. patients with a baseline QTcF >450 ms in males, and >460ms in females. Or patients with uncontrolled (despite supplementation) hypokalemia or hypomagnesaemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
- •8. Patients with clinically significant valvular disease
- •9. Patients with symptomatic cholelithiasis
- •10. Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, advanced heart block, history of acute myocardial infarction less than one year prior to study entry or clinically significant impairment in cardiovascular function
- •11. Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST > 2.5 X ULN, serum bilirubin > 2.0 X ULN, in the absence of liver metastases
- •12. Patients who have a history of alcohol or drug abuse in the 6 month period prior to receiving pasireotide
- •13. Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
- •14. Patients with the presence of active or suspected acute or chronic uncontrolled infection
- •15. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
- •16. Pregnant or lactating women
- •17. At the time of inclusion, on-going AE considered to be related to the treatment with SSA with a severity higher than grade 1
- •18. Patients on lower doses than octreotide LAR 30mg every 28 days.
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