What side effects are associated with this type of intervention?

The most common treatments for Carcinoid Syndrome, particularly somatostatin receptor agonists like octreotide and lanreotide, are generally well-tolerated but can have side effects. These may include gastrointestinal issues such as nausea, diarrhea, and abdominal pain. Other potential side effects are gallstones, hyperglycemia, and injection site reactions. Long-term use can sometimes lead to decreased thyroid function and vitamin B12 deficiency. It is important for patients to discuss these potential side effects with their healthcare provider to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several somatostatin receptor agonists for the treatment of Carcinoid Syndrome. Notably, octreotide (Sandostatin) and lanreotide (Somatuline Depot) are long-acting somatostatin analogs that have been widely used to manage symptoms associated with Carcinoid Syndrome by inhibiting the release of various hormones. These treatments help control symptoms such as flushing and diarrhea, which are common in patients with Carcinoid Syndrome.

What other types of research exist?

Promising novel alternatives to Paltusotine for Carcinoid Syndrome patients include Lutetium Lu 177 dotatate (a radiolabeled somatostatin analog used in peptide receptor radionuclide therapy) and selective RET inhibitors like Selpercatinib and Pralsetinib, which have shown efficacy in treating neuroendocrine tumors. These treatments offer new mechanisms of action and have demonstrated positive outcomes in clinical trials.

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Somatostatin Analog

Paltusotine for Carcinoid Syndrome

Phase 2

Waitlist Available

Research Sponsored by Crinetics Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Documented carcinoid syndrome requiring medical therapy

Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor (NET)

Must not have

Diarrhea attributed to any condition(s) other than carcinoid syndrome

Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at week 8

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called paltusotine to see if it is safe and how it behaves in people with carcinoid syndrome. Researchers want to understand how the drug moves through the body and its effects at different doses. The study includes a part where patients receive different treatments and a part where all patients receive paltusotine.

Who is the study for?

This trial is for adults with carcinoid syndrome not currently treated with certain somatostatin receptor ligands or those controlled on lanreotide/octreotide. Participants should have stable disease, no recent other NET treatments, and can't have insulin-treated diabetes less than 6 weeks old, severe diarrhea from other causes, or require second-line treatments.

What is being tested?

The study tests the safety and dose response of Paltusotine (80 mg or 40 mg) in patients with carcinoid syndrome. It includes a randomized phase where doses are compared by chance and an open-label phase where all receive the drug.

What are the potential side effects?

While specific side effects aren't listed here, typically such trials monitor for digestive issues like diarrhea (given the condition), hormonal imbalances due to serotonin levels affected by tumors, and general medication reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am on medication for carcinoid syndrome.

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My cancer is a well-differentiated neuroendocrine tumor that has spread.

Exclusion Criteria

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

Select...

My diarrhea is not caused by carcinoid syndrome.

Select...

I have severe diarrhea causing dehydration or low blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at week 8 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Pharmacokinetics (PK) of paltusotine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: 80 mg PaltusotineExperimental Treatment1 Intervention

Group II: 40 mg PaltusotineExperimental Treatment1 Intervention

0 / 4Eligibility 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 receptor agonists, such as octreotide and lanreotide, are commonly used to treat Carcinoid Syndrome. These drugs mimic the action of the natural hormone somatostatin, binding to somatostatin receptors on neuroendocrine tumor cells. This binding inhibits the release of various hormones and peptides that cause the symptoms of Carcinoid Syndrome, such as flushing and diarrhea. By controlling these symptoms, somatostatin receptor agonists improve the quality of life for patients and can also slow tumor growth. The importance of these treatments lies in their ability to manage both the hormonal symptoms and the progression of the disease, making them a cornerstone in the management of Carcinoid Syndrome.

Evaluating the characteristics and the management of patients with neuroendocrine tumors receiving octreotide LAR during a 6-year period.