What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Tumors (NETs) using somatostatin analogs such as octreotide and lanreotide can lead to several side effects. These include gastrointestinal issues like diarrhea, abdominal pain, and nausea. Patients may also experience gallstones, hyperglycemia, and injection site reactions. Long-term use can sometimes result in more serious conditions such as myelodysplastic syndrome or nephrotoxicity. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several somatostatin analogs for the treatment of Neuroendocrine Tumors (NETs). Octreotide LAR (Sandostatin LAR) and lanreotide ATG (Somatuline Depot) are two key drugs in this category. These medications have been shown to control symptoms and delay tumor progression in patients with advanced NETs. The PROMID and CLARINET trials provided significant evidence supporting their efficacy, leading to their approval for use in patients with gastroenteropancreatic NETs.

What other types of research exist?

Promising novel alternatives to CAM2029 for NETs patients include: 1) Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Dotatate, which has shown significant efficacy in patients with somatostatin receptor-positive tumors. 2) Everolimus, an mTOR inhibitor, which has demonstrated effectiveness in controlling tumor growth in advanced NETs. 3) Surufatinib, a tyrosine kinase inhibitor, which has shown positive results in clinical trials for advanced extrapancreatic NETs. These alternatives offer different mechanisms of action and have been supported by clinical evidence for their efficacy in treating NETs.

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Somatostatin Analog

Octreotide Depot for Neuroendocrine Tumors (SORENTO Trial)

Phase 3

Waitlist Available

Led By Simron Singh, MD, MPH

Research Sponsored by Camurus AB

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 to 2

Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin

Must not have

Known central nervous system metastases

Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years following the primary efficacy analysis

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include digestive issues such as diarrhea or stomach pain; blood sugar changes; gallstones; injection site reactions; fatigue; and possibly allergic reactions. The exact side effects will vary between the medications being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain.

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

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I have had radioligand therapy before.

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My cancer has worsened despite treatment.

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I have had more than one round of specific treatments for my neuroendocrine tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years following the primary efficacy analysis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years following the primary efficacy analysis

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years following the primary efficacy analysis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)

Secondary study objectives

Disease control rate

Duration of response

Overall response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CAM2029Experimental Treatment1 Intervention

Group II: Octreotide LAR or lanreotide ATGActive Control2 Interventions

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Somatostatin analogs, such as octreotide and lanreotide, work by binding to somatostatin receptors on neuroendocrine tumor cells, inhibiting the release of hormones and growth factors that promote tumor growth. This mechanism is crucial for controlling symptoms and slowing disease progression in NET patients. mTOR inhibitors like everolimus target the mTOR pathway, which is involved in cell growth and proliferation, thereby reducing tumor growth. Peptide receptor radionuclide therapy (PRRT) uses radiolabeled somatostatin analogs to deliver targeted radiation to tumor cells, causing cell death. These treatments are essential for managing NETs as they offer symptom relief, control tumor growth, and improve quality of life.

The Current Role of Peptide Receptor Radionuclide Therapy in Meningiomas.Systemic Treatment Options for Carcinoid Syndrome: A Systematic Review.Treatment Patterns and Burden of Illness in Patients Initiating Targeted Therapy or Chemotherapy for Pancreatic Neuroendocrine Tumors.