Study on the Safety and Effects of Paltusotine and Octreotide Acetate for Patients with Carcinoid Syndrome

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What is this study about?

This clinical trial is focused on studying Carcinoid Syndrome, a condition that arises from certain types of tumors called neuroendocrine tumors. These tumors can release hormones into the bloodstream, causing symptoms like flushing, diarrhea, and wheezing. The study will evaluate a new treatment called Paltusotine, which is taken as a tablet. Paltusotine is also known by its code name, CRN00808. The purpose of the study is to assess the safety and how the body processes different doses of Paltusotine in individuals with Carcinoid Syndrome.

Participants in the study will receive Paltusotine in varying doses of 40, 80, or 120 milligrams per day. The study will also involve a comparison with another treatment called Octreotide Acetate, which is a solution for injection. Octreotide Acetate is a synthetic version of a natural hormone that helps control symptoms of Carcinoid Syndrome. Some participants may receive a placebo instead of the active medication. The study will monitor participants over a period to observe any side effects and how well the medication is tolerated.

Throughout the study, participants will undergo regular check-ups, including laboratory tests and heart monitoring, to ensure their safety. The study aims to gather information on how Paltusotine affects the body and its potential as a treatment for managing symptoms of Carcinoid Syndrome. This research could provide valuable insights into new ways to help people living with this condition.

1 Initial Visit and Baseline Assessment

Upon joining the study, an initial visit is conducted to assess eligibility and establish baseline health parameters. This includes a review of medical history, physical examination, and laboratory tests.

Participants are required to provide informed consent and agree to comply with study procedures.

2 Medication Washout (if applicable)

For participants currently using medications like lanreotide or octreotide, a washout period is necessary. This involves stopping the medication to observe any changes in symptoms.

Symptomatic worsening is monitored to confirm eligibility for the study.

3 Randomization and Start of Treatment

Participants are randomly assigned to receive one of the following doses of paltusotine: 40 mg, 80 mg, or 120 mg, taken orally once daily.

The treatment aims to evaluate the safety and how the body processes the medication.

4 Regular Monitoring and Assessments

Throughout the study, regular visits are scheduled to monitor health status, including physical exams, laboratory tests, and heart monitoring for those on the 120 mg dose.

Participants are required to maintain a symptom diary to track any changes or side effects.

5 End of Treatment and Final Evaluation

At the end of the treatment period, a final evaluation is conducted to assess the overall safety and effectiveness of the medication.

This includes a comprehensive review of all collected data, including symptom diaries and laboratory results.

Who Can Join the Study?

Must be willing and able to provide written consent before any study-related activities.
If male, must agree to use a condom during sexual activity with a female partner who can have children, or be surgically sterile (e.g., vasectomy), or choose not to have sex. Must also agree not to donate sperm during the study and for 30 days after the last dose of the study drug.
Must be willing and able to follow the study procedures, including using an electronic Symptom Diary at least 70% of the time for two weeks before certain study visits.
Must be 18 years or older at the time of the initial screening.
Must have documented Carcinoid Syndrome that requires medical treatment. This includes:
- Not currently treated with certain medications for at least 12 weeks before screening and showing symptoms. This can include those who have never been treated.
- Currently treated with specific medications (lanreotide, octreotide LAR, or short-acting octreotide) and willing to stop these medications. Must show worsening symptoms after stopping. Must have a history of elevated blood markers or serotonin levels.
Must have documentation of a locally advanced or metastatic well-differentiated neuroendocrine tumor (NET). Tumors must be Grade 1 or Grade 2, which means they grow slowly. Grade 3 tumors are not eligible.
No significant disease progression in the last 6 months before starting the study drug. This means the disease has not gotten worse, as shown by recent imaging tests like MRI or CT scans.
Must have historical documentation showing positive somatostatin receptor (SSTR) tumor status through specific imaging tests. If not available, this can be done during screening.
For those not currently treated with any specific therapy and not stopping such therapy, blood markers must be above the normal limit during screening.
Females who have heterosexual intercourse must be unable to have children, either due to surgery or being postmenopausal, or must agree to use a highly effective birth control method from the start of screening to the last study visit. Acceptable methods include:
- Combined hormonal birth control pills that prevent ovulation.
- Progestin-only birth control methods that prevent ovulation, including pills, injections, and implants.
- Hormone delivery methods used inside the vagina or on the skin.
- Intrauterine devices (IUDs), with or without hormones.
- Surgical procedures like tubal ligation (must be documented).
- Partner with a vasectomy (must be documented).
- Choosing not to have sex, if this is the usual lifestyle.
In addition, the male partner should use a condom from the start of screening to the last study visit.

Who Cannot Join the Study?

Having any other serious health condition that might interfere with the study.
Being pregnant or breastfeeding.
Having a history of allergic reactions to similar medications.
Using certain medications that might interact with the study drug.
Having participated in another clinical trial recently.
Having a history of substance abuse.
Having a mental health condition that might affect participation.
Having abnormal lab test results that are not explained by the current condition.
Having a history of certain heart conditions.
Having uncontrolled high blood pressure.
Having liver or kidney problems that are not stable.
Being unable to follow the study procedures or instructions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Dkyveuqlokjx Cjcsupd Oejyoeboq Pqtaixerlvtq I Hfzgsspwhxy	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	20.10.2023

Trial locations

Investigated drugs:

Paltusotine is a medication being studied for its potential to treat carcinoid syndrome. This condition is associated with certain types of tumors that can cause a variety of symptoms due to hormone release. The trial aims to evaluate the safety and how the body processes different doses of paltusotine. Participants in the study will receive this medication to help determine the best dose that balances effectiveness with minimal side effects.

Carcinoid Syndrome – Carcinoid Syndrome is a group of symptoms that occur in some people with carcinoid tumors, which are slow-growing tumors that can arise in several places throughout the body. These tumors often release hormones such as serotonin into the bloodstream, leading to symptoms like flushing of the skin, diarrhea, and wheezing. Over time, the syndrome can cause damage to heart valves and other organs due to the continuous release of these hormones. The symptoms can vary in intensity and may be triggered by stress, certain foods, or alcohol. The progression of the syndrome is closely linked to the growth and activity of the underlying carcinoid tumors.

Trial ID:

2024-511922-30-00

Protocol code:

CRN00808-11

NCT ID:

NCT05361668

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Paltusotine and Octreotide Acetate for Patients with Carcinoid Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?