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Varegacestat

Clinical trials investigating Varegacestat are studying whether it can help people with progressing desmoid tumors. The trials are designed to evaluate safety, tolerability, and effects on disease progression in affected patients. They include different study parts and compare treatment with placebo in some phases.

Table of Contents

Trial overview

The available trial data describe one interventional study of Varegacestat in people with progressing desmoid tumors.[1] The study is authorised and includes 198 participants.[1]

The brief summary says the research is designed to look at safety, tolerability, and effects on disease progression in subjects with progressing or progressive desmoid tumors.[1]

Study parts and phase

The trial is listed as Phase 4, but the brief summary also describes separate parts of the study as Phase II and Phase III.[1] This means the source data present the study as a multi-part research program rather than a single simple phase.

Part A is focused on safety and tolerability, Part B is focused on disease progression, and the open-label extension, or OLE, continues safety and tolerability follow-up.[1]

Who the trials are for

The study targets subjects with progressing desmoid tumors or progressive desmoid tumors.[1] In simple terms, this means the tumor is not stable and is continuing to grow or worsen.

The source data do not list the full eligibility rules, such as age limits or prior treatment rules.[1] So, the exact group who can join is not fully described in the provided trial record.

What is being measured

The main safety outcomes are the frequency and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).[1] TEAEs are health problems that start or get worse after treatment begins, while SAEs are more severe problems that may need urgent care.

Another safety-related endpoint is the time to treatment discontinuation because of a TEAE.[1] This shows how long people stay on treatment before side effects lead to stopping the study drug.

The main efficacy, or benefit, outcome listed for Part B is progression-free survival.[1] This means the researchers are measuring how long the disease does not get worse during the study.

Treatment groups and placebo

The intervention list includes AL102 at 4 mg and 1.2 mg by oral use, plus a placebo capsule.[1] The provided trial record does not explain the relationship between AL102 and Varegacestat, so the article only reports the source data as written.

A placebo is a capsule that looks like the study treatment but does not contain the active drug.[1] Researchers use it to help compare results in a fair way.

Study size and status

The study enrollment is listed as 198, which is the planned or total number of participants in the trial record.[1] The trial status is Authorised.[1]

Because the source data only provide one trial, the clinical research picture for Varegacestat in this dataset is focused on progressing desmoid tumors and on measuring safety plus disease control.[1]

Trial ID Phase Condition studied Status Enrollment
2024-515909-26-00 Phase 4 Progressing desmoid tumors Authorised 198

FAQ

  • What are the clinical trials of Varegacestat studying? The trials are studying Varegacestat in people with progressing desmoid tumors. They focus on safety, tolerability, and whether the treatment can slow disease progression.
  • Who may take part in these trials? The study data describe subjects with progressing desmoid tumors or progressive desmoid tumors. The exact eligibility rules are not listed in the source data, so participation depends on the study team’s screening.
  • What phase is the Varegacestat trial? The trial is listed as Phase 4. The brief summary also describes different parts of the study, including a Phase II part and a Phase III part.
  • What outcomes are being measured? The trials measure the frequency and severity of treatment-emergent adverse events, or TEAEs, and serious adverse events, or SAEs. They also measure time to treatment discontinuation because of a TEAE and progression-free survival.
  • Is placebo used in the study? Yes. The trial includes a placebo capsule in the listed interventions. A placebo looks like the study drug but does not contain the active treatment.

Ongoing Clinical Trials on Varegacestat

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Glossary

  • Desmoid tumors: A type of tumor that can grow in nearby tissues. In these trials, the tumors are described as progressing or progressive, meaning they are getting worse or continuing to grow.
  • Progressing: A condition that is getting worse over time. In this study, it means the tumor is not stable and is continuing to change.
  • Interventional study: A clinical trial where participants receive a treatment or placebo so researchers can compare outcomes.
  • Phase 4: A later stage of clinical research. Studies in this phase often look more closely at safety and how a treatment works in a larger group.
  • Phase II: An earlier research phase that usually focuses on safety and whether a treatment shows signs of helping.
  • Phase III: A larger research phase that compares a treatment with another option, often to see how well it works.
  • Placebo: A capsule that looks like the study treatment but does not contain the active drug. It helps researchers compare results fairly.
  • Safety and tolerability: How well people can take a treatment and what side effects or problems may happen during the study.
  • Treatment-emergent adverse events (TEAEs): Unwanted medical problems that start or get worse after treatment begins.
  • Serious adverse events (SAEs): Medical problems that are severe and may need urgent care, hospital treatment, or may be life-threatening.
  • Progression-free survival: The length of time during and after treatment that the disease does not get worse.
  • Open-label extension (OLE): A study period where participants may continue treatment and researchers keep watching safety and tolerability.

References

  1. https://clinicaltrials.gov/study/2024-515909-26-00