NL-OMON54375招募中3 期
A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with gastroenteropancreatic neuroendocrine tumors - HS-19-657 / SORENTO
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Camurus AB
- 入组人数
- 21
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
- •Main Inclusion Criteria for the Trial
- •Male or female patient >=18 years old
- •Histologically confirmed, advanced (unresectable and/or metastatic), and
- •well-differentiated NET of GEP or presumed GEP origin
- •At least 1 measurable, somatostatin receptor-positive*, lesion according to
- •RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before
- •randomization)
- •*Somatostatin-receptor imaging must be performed within 12 months before
- •randomization. Somatostatin receptor-positive lesions are defined as lesions
- •with a visual assessment of uptake greater than the liver
- •Results from FDG-PET CT for patients with well-differentiated Grade 3 NET (if
- •performed) must show that FDG avid areas of disease also are avid on
- •somatostatin-receptor imaging
- •ECOG performance status of 0 to 2
- •Main Inclusion Criteria for the Extension Treatment Period
- •Disease progression confirmed by the BIRC
- •At least 6 months of treatment with IMP (CAM2029/comparator) in the
- •Randomized Treatment Period before documented disease progression
排除标准
- •Main Exclusion Criteria for the Trial
- •Documented evidence of disease progression while on treatment (including
- •SSAs) for locally advanced unresectable or metastatic disease
- •Known central nervous system metastases
- •Consecutive treatment with long-acting SSAs for more than 6 months before
- •randomization
- •Carcinoid symptoms that are refractory to treatment (according to the
- •Investigator's judgement) with conventional doses of octreotide LAR or
- •lanreotide ATG and/or to treatment with daily doses of <=600 µg of octreotide IR
- •Previous treatment with more than 1 cycle (where 1 cycle means <=28 days on
- •treatment) of targeted therapies such as mammalian target of rapamycin (mTOR)
- •inhibitors (e.g. sirolimus, temsirolimus, or everolimus) or vascular
- •endothelial growth factor inhibitors (e.g. sunitinib, lenvatinib, or
- •cabozantinib), or more than 1 cycle of chemotherapy or interferon for GEP-NET
- •Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial
- •embolization within 12 months before screening
- •Previously received radioligand therapy (peptide receptor radionuclide
- •therapy) at any time
- •Hepatic/pancreatic-related exclusion criteria:
- •*Active hepatitis. Patients with no significant viral load, no acute signs of
- •inflammation, and no clinical necessity for therapy are allowed, at the
- •Investigator*s discretion
- •* Symptomatic cholelithiasis
- •* Clinically active or chronic liver disease, including liver cirrhosis of
- •Child-Pugh class B or C
- •Patients with poorly controlled diabetes, as evidenced by hemoglobin A1c
- •(HbA1c) >8.0%
- •Cardiac history or current diagnosis of cardiac disease indicating
- •significant risk of safety for patients participating in the trial, such as
- •uncontrolled or significant cardiac disease, including any of the following:
- •* History of myocardial infarction, unstable angina pectoris, or coronary
- •artery bypass graft within 6 months before screening
- •* Uncontrolled congestive heart failure
- •Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia),
- •complete left bundle branch block, or high-grade atrioventricular block (e.g.
- •bifascicular block, Mobitz type II, and third-degree atrioventricular block)
- •Long QT syndrome, family history of idiopathic sudden death or congenital
- •long QT syndrome, or any of the following:
- •* Risk factors for Torsades de Pointes, including uncorrected hypokalemia or
- •hypomagnesemia, history of cardiac failure, or history of clinically
- •significant/symptomatic bradycardia
- •*Treatment with concomitant medication(s) with a known risk of Torsades de
- •Pointes per www.crediblemeds.org that cannot be discontinued or replaced with
- •safe alternative medication at least 7 days or 5 half-lives (whichever is
- •longer) before start of IMP treatment
- •* Patients with a QTc interval corrected by Fridericia's formula >450 msec
- •for males and >470 msec for females at screening
- •Any other contraindicated serious medical condition that, in the
- •Investigator's opinion, may prevent the patient from safely participating in
- •Main Exclusion Criteria for the Extension Treatment Period
- 另有 3 项未显示
研究者
相似试验
进行中（未招募）
1 期
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NETgastroenteropancreatic neuroendocrine tumorsMedDRA version: 20.0Level: PTClassification code 10077559Term: Gastroenteropancreatic neuroendocrine tumour diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-000849-40-HUCamurus AB302
进行中（未招募）
1 期
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NETEUCTR2021-000849-40-ESCamurus AB302
进行中（未招募）
1 期
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NETEUCTR2021-000849-40-NLCamurus AB300
进行中（未招募）
1 期
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NETgastroenteropancreatic neuroendocrine tumorsMedDRA version: 20.0Level: PTClassification code 10077559Term: Gastroenteropancreatic neuroendocrine tumour diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10077560Term: Gastroenteropancreatic neuroendocrine tumor diseaseSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-000849-40-ITCamurus AB302
进行中（未招募）
1 期
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NETEUCTR2021-000849-40-DECamurus AB300