Octreotide Depot for Neuroendocrine Tumors

(SORENTO Trial)

Recruiting at 100 trial locations

Overseen By Camurus AB

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Camurus AB

Must not be taking: mTOR inhibitors, Chemotherapy

Disqualifiers: CNS metastases, Refractory carcinoid symptoms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

332 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CAM2029, a new treatment for patients with advanced GEP-NET, a type of cancer. The goal is to see if CAM2029 works better and is safer than current treatments. If patients' cancer worsens, they can receive more intensive treatment with CAM2029.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently on long-acting somatostatin analogs (SSAs) for more than 6 months, you may not be eligible to participate.

What data supports the effectiveness of the drug CAM2029, Lanreotide ATG, Octreotide LAR for neuroendocrine tumors?

Lanreotide, one of the drugs in the treatment, has been shown to effectively control symptoms and inhibit tumor growth in patients with neuroendocrine tumors. Studies have reported that lanreotide can improve progression-free survival and manage symptoms like diarrhea and flushing in these patients. ^{1 2 3 4 5}

Is Octreotide Depot safe for treating neuroendocrine tumors?

Octreotide Depot, also known as lanreotide, has been generally well tolerated in patients with neuroendocrine tumors, though some have experienced side effects like fatigue, diarrhea, nausea, high blood pressure, and high blood sugar. These treatments have been used safely in various studies, even when patients switched from other similar medications. ^{2 4 6 7 8}

How is the drug CAM2029 different from other treatments for neuroendocrine tumors?

CAM2029, like lanreotide and octreotide, is a somatostatin analog used to treat neuroendocrine tumors, but it may offer a unique formulation or delivery method that could improve patient experience or treatment outcomes. Lanreotide, for example, is known for its sustained-release formulation, which can help control symptoms and inhibit tumor growth effectively. ^{3 4 5 9 10}

Research Team

Simron Singh, MD, MPH

Principal Investigator

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Eligibility Criteria

This trial is for adults with advanced, well-differentiated neuroendocrine tumors of the gut or pancreas. Participants must have at least one measurable lesion and be in fairly good health (ECOG status 0-2). They shouldn't have brain metastases, extensive prior treatments like long-term SSAs, chemoembolization within a year, radioligand therapy ever, or unmanageable carcinoid symptoms.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

My cancer is a type that started in the digestive system and cannot be surgically removed.

I have a tumor visible on scans that responds to a specific hormone.

Exclusion Criteria

My cancer has spread to my brain.

I have not had specific artery treatments for my NET in the last year.

I have been on long-acting SSAs for over 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CAM2029 or octreotide LAR/lanreotide ATG for comparison of effectiveness and safety

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Open-label extension

Participants with progressive disease may receive intensified treatment with CAM2029

Treatment Details

Interventions

• CAM2029
• Lanreotide ATG
• Octreotide LAR

Trial Overview The study tests CAM2029 against two established drugs: octreotide LAR and lanreotide ATG. It aims to see which is more effective and safer for patients with GEP-NET. If disease progresses during the study, participants may receive an intensified treatment of CAM2029 in an open-label extension part.

Participant Groups

Group I: CAM2029 Experimental Treatment 1 Intervention

Group II: Octreotide LAR or lanreotide ATG Active Control 2 Interventions

Who Is Running the Clinical Trial?

Camurus AB

Lead Sponsor

Trials

9

Recruited

1,900+

Findings from Research

Lanreotide depot, a sustained-release formulation of a somatostatin analog, has been shown to improve progression-free survival (PFS) and control symptoms in patients with unresectable gastroenteropancreatic neuroendocrine tumors (GEP-NETs), demonstrating its efficacy in long-term clinical studies.

The unique formulation of lanreotide depot, which consists solely of lanreotide acetate and water, enhances its pharmacokinetic profile and offers a promising model for developing other sustained-release peptide therapies, while being well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lanreotide Depot: An Antineoplastic Treatment of Carcinoid or Neuroendocrine Tumors. Wolin, EM., Manon, A., Chassaing, C., et al.[2018]

References

1. Poland pubmed.ncbi.nlm.nih.gov

LanroNET, a non-interventional, prospective study to assess the resource utilization and cost of lanreotide autogel 120 mg in Polish patients with neuroendocrine tumors - results of interim analysis. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel: Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment with Lanreotide Depot Following Octreotide Long-Acting Release Among Patients with Gastroenteropancreatic Neuroendocrine Tumors. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Lanreotide Depot: An Antineoplastic Treatment of Carcinoid or Neuroendocrine Tumors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

EVALUATION OF LANREOTIDE DEPOT/AUTOGEL EFFICACY AND SAFETY AS A CARCINOID SYNDROME TREATMENT (ELECT): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

A qualitative study to understand the experience of somatostatin analog treatments from the perspective of patients with neuroendocrine tumors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal neuroendocrine tumors treated with high dose octreotide-LAR: a systematic literature review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comparing the Cost of Treatment with Octreotide Long-Acting Release versus Lanreotide in Patients with Metastatic Gastrointestinal Neuroendocrine Tumors. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

LANREOTIDE THERAPY IN CARCINOID SYNDROME: PROSPECTIVE ANALYSIS OF PATIENT-REPORTED SYMPTOMS IN PATIENTS RESPONSIVE TO PRIOR OCTREOTIDE THERAPY AND PATIENTS NAÏVE TO SOMATOSTATIN ANALOGUE THERAPY IN THE ELECT PHASE 3 STUDY. [2022]