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Tests treatment safety and results for Carcinoid Syndrome
Official title Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
ClinicalTrials.gov ID: NCT07087054
What this study is testing
What is Paltusotine?
Paltusotine is an investigational medicine, being studied as a potential treatment for carcinoid syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female ≥18 years of age, at the time of Screening.
- Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the...
- Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
- For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \>1 flushing...
- For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing...
You likely can't join if
- Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
- Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
- Treatment with specific NET therapy \<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide...
- Major surgery within 8 weeks before Screening.
- History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of...
See the full eligibility criteria
- Male or female ≥18 years of age, at the time of Screening.
- Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.
- Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:
- For participants who are naïve/not currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \>1 flushing episode/day over a period of 14 days
- For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing episodes and an average of \>1 flushing episode/day over a period of 14...
- Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) [NETs].
- No significant disease progression as assessed by the Investigator within the last 6 months before randomization.
- Diarrhea attributed to any condition(s) other than carcinoid syndrome.
- Uncontrolled/severe diarrhea associated with significant volume contraction, dehydration, or hypotension.
- Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.
- Treatment with specific NET therapy \<4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and/or tumor debulking \<12 weeks...
- Major surgery within 8 weeks before Screening.
- History of another primary malignancy \<3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast has been completely locally excised...
- Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.
- Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%
- Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.
- Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate...
- Alcohol or drug abuse is not permitted at any time during the study
- Diagnosed with symptomatic cholelithiasis
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Newport Beach, California, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Metairie, Louisiana, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Charlottesville, Virginia, United States
- Milwaukee, Wisconsin, United States
- Buenos Aires, Argentina
- Santa Fe, Argentina
- São Paulo, Brazil, Brazil
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Newport Beach, California, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Tampa, Florida, United States; Atlanta, Georgia, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.