Octreotide Depot for Neuroendocrine Tumors

(SORENTO Trial)

Not currently recruiting at 106 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CAM2029 for individuals with advanced neuroendocrine tumors (NETs) in the stomach, intestines, or pancreas. The goal is to determine if CAM2029 is more effective and safer than the usual treatments, octreotide LAR and lanreotide ATG. Individuals with NETs that cannot be surgically removed and continue to grow might be suitable candidates. Participants will begin with one of these treatments, and if their condition worsens, they can switch to a more intense CAM2029 treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CAM2029 is as safe as current standard treatments like octreotide LAR and lanreotide ATG. Studies have found that patients using CAM2029 report satisfaction with their treatment and maintain a good quality of life over time, indicating that CAM2029 is generally well-tolerated.

Octreotide LAR and lanreotide ATG are already used for other conditions, and their safety is well-understood and manageable. These treatments are usually well-tolerated, with few serious side effects reported in past studies. Therefore, participants in this trial can feel confident about the safety of these treatments based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CAM2029 for treating neuroendocrine tumors because it offers a unique delivery method. Unlike the standard treatments, such as Octreotide LAR or Lanreotide ATG, which require deep intramuscular injections, CAM2029 is designed for subcutaneous injection. This means it can be administered more easily and potentially with less pain. Additionally, CAM2029 may allow for more consistent drug release, leading to improved management of symptoms associated with neuroendocrine tumors.

What evidence suggests that this trial's treatments could be effective for neuroendocrine tumors?

Research has shown that CAM2029, one of the treatments studied in this trial, could be promising for treating neuroendocrine tumors. Studies found that CAM2029 delivers about 500% more of the drug octreotide in the bloodstream compared to the current treatment, octreotide LAR. This increased concentration might lead to better patient outcomes. Additionally, CAM2029 has successfully normalized IGF-1 levels in patients with acromegaly, suggesting it might help control hormone-related symptoms. While octreotide LAR and lanreotide ATG are the usual treatments and serve as comparators in this trial, CAM2029's improved delivery could offer a significant advantage. ^{1 2 6 7 8}

Who Is on the Research Team?

Simron Singh, MD, MPH

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. camurus.com camurus.com/media/press-releases/2023/camurus-announces-completed-enrollment-in-the-phase-3-sorento-study-of-cam2029-in-patients-with-neuroendocrine-tumors/

Camurus announces completed enrollment in the Phase 3 ... The primary endpoint is to demonstrate statistically significant increased progression-free survival of treatment with CAM2029 compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790497/

Methodology of the SORENTO clinical trial - PubMed Central This trial will investigate the efficacy and tolerability of CAM2029 compared to the current SoC, including octreotide LAR and lanreotide autogel (ATG).

3. nanets.net nanets.net/abstracts-archive/2023-1/1896-t8-singh-status-of-the-ongoing-sorento-clinical-trial-assessing-efficacy-and-safety-of-high-exposure-octreotide-subcutaneous-depot-in-patients-with-gep-net/file

Status of the ongoing SORENTO clinical trial Clinical trials showed ~500% higher octreotide bioavailability with CAM2029 versus octreotide long-acting release (LAR), and maintenance/reduction of NET ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05050942

NCT05050942 | A Trial to Assess Efficacy and Safety of ... The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well- ...

5. camurus.com camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/

Camurus announces positive Phase 3 results from the ... CAM2029 octreotide SC depot was effective in normalizing IGF-1 levels across patient groups and continuously improving symptoms of acromegaly throughout the 52 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05050942

Study Details | NCT05050942 | A Trial to Assess Efficacy ... The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12545632/

SUN-045 Improved Patient-Reported Outcomes with ... Conclusions: CAM2029 showed a long-term safety profile similar to SoC. Patients experienced continuous improvements in QoL and treatment satisfaction scores ...

8. academic.oup.com academic.oup.com/jcem/article/110/6/1729/7815757

A Randomized, Double-blind, Placebo-controlled Phase 3 ... Collectively, these data suggest that CAM2029 is a treatment option that is both effective and convenient, contributing to a more favorable overall treatment ...