BridgeMD
A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NET
EU CTIS ID: 2023-508723-12-00
What this study is testing
To assess superiority of treatment with CAM2029 compared to treatment with octreotide long-acting release (LAR) or lanreotide autogel (ATG) on progression-free survival (PFS) in patients with unresectable/metastatic and well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NET)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
- 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 the trial
- Known central nervous system metastases
See the full eligibility criteria
Who can join
- 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
What rules you out
- Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
- 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 the trial
- 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%
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Israel
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Israel; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.