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
- Conditions
- gastroenteropancreatic neuroendocrine tumorsneuroendocrine tumor which started in pancreas or other parts gastrointestinal tract10027655
- Registration Number
- NL-OMON54375
- Lead Sponsor
- Camurus AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 21
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
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
the trial
Main Exclusion Criteria for the Extension Treatment Period
• Unresolved, drug-related serious adverse event that, in the Investigator's
opinion, contraindicates treatment with CAM2029
• Clinically significant symptoms, medical conditions, rapid clinical
deter
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>• PFS, defined as the time from the date of randomization to the date of the<br /><br>first documented disease progression as per Response Evaluation Criteria in<br /><br>Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever<br /><br>occurs first, as assessed by a Blinded Independent Review Committee (BIRC)</p><br>
- Secondary Outcome Measures
Name Time Method