Study on the Safety and Effects of Vimseltinib for Patients with Advanced Tumors and Tenosynovial Giant Cell Tumor

2 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called vimseltinib, also known by its code name DCC-3014. The study is designed to assess the safety and effectiveness of this medication in patients with advanced tumors and a specific type of tumor called tenosynovial giant cell tumor (TGCT). TGCT is a condition that affects the joints and can cause pain and stiffness. The purpose of the study is to understand how well vimseltinib works in treating these conditions and to determine the best dose for future use.

Participants in the study will take vimseltinib in the form of a hard capsule, which is taken orally. The study will monitor the participants over a period of time to observe any side effects and to measure how the medication is processed in the body. This includes looking at how long it takes for the medication to reach its highest level in the blood and how long it stays in the system. The study will also evaluate the medication’s ability to reduce the size of the tumors using specific criteria for measuring tumor response.

The trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study will continue until the researchers gather enough information to determine the safety and effectiveness of vimseltinib for treating advanced tumors and TGCT. The findings from this study will help guide future research and treatment options for these conditions.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

A tumor biopsy may be required to confirm the diagnosis of tenosynovial giant cell tumor if previous histology is not available.

2 medication administration

The medication used in this study is called DCC-3014, also known as vimseltinib. It is administered in the form of a hard capsule taken orally.

The dosage and frequency of administration will be determined based on the study protocol and individual patient needs.

3 monitoring and evaluation

Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes physical examinations, laboratory tests, and imaging studies.

Patients are evaluated for any side effects or adverse reactions to the medication.

4 response assessment

The response to the treatment is assessed using specific criteria, such as the Response Evaluation Criteria in Solid Tumors (RECIST).

This assessment helps determine the effectiveness of the medication in reducing tumor size or slowing disease progression.

5 completion of study

The study is expected to continue until September 2026. Upon completion, a final assessment is conducted to evaluate the overall outcomes of the treatment.

Patients may be provided with follow-up care or recommendations based on their individual health status and study results.

Who Can Join the Study?

  • Must be a male or female patient who is at least 18 years old.
  • Must be able to take medicine by mouth.
  • If you can have children, you must have a negative pregnancy test (for women) and agree to use birth control.
  • Must understand the study details and agree to participate by signing a consent form.
  • Must be willing and able to complete assessments on an electronic device.
  • Must have a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT), which may require a tumor biopsy if no previous test results are available.
  • Must have a condition where surgery could lead to worse physical limitations or serious health issues, as determined by a medical team.
  • Must have symptoms like moderate pain or stiffness, with a score of 4 or more out of 10, recorded within 30 days before starting the study.
  • Must complete 14 days of questionnaires during the screening period and meet specific requirements.
  • If taking pain medication, it must be stable for at least 2 weeks before starting the study.
  • For certain participants, must have had previous treatment with specific therapies, except for imatinib or nilotinib.
  • Must have at least one measurable tumor, as defined by specific medical criteria, and it can be in an area that was previously treated with radiation if it shows signs of growth.
  • Must have adequate organ function and bone marrow health, shown by specific lab tests done within 21 days before starting the study.

Who Cannot Join the Study?

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to similar medications are excluded.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, are not eligible.
  • Those who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot join the study.
  • Participants who have received another investigational drug within the last 4 weeks are excluded.
  • Individuals with active infections that require treatment are not allowed to participate.
  • Patients with significant heart problems, such as heart failure or recent heart attack, are excluded.
  • Those with liver disease or abnormal liver function tests cannot join the study.
  • Individuals with a history of drug or alcohol abuse within the last year are not eligible.
  • Patients who have had major surgery within the last 4 weeks are excluded.
  • Participants with a known history of HIV, hepatitis B, or hepatitis C are not allowed to participate.
  • Individuals who are unable to comply with the study procedures or follow-up visits are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Istituto Ortopedico Rizzoli Bologna Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Cgpevw Luiw Bkiarl Lyon France
Izejtc Ihqagiay Fdihaywmatitl Osrxhmwglnk Rome Italy
Lbwxe Uukqnqeeiaph Mwgxsdq Ccboavg (ldrys Leiden The Netherlands
Nwfvkxjc Igeutsun Oygynaydk Ihe Mdftw Syeknuwjvteyzjlhshwcimbzcqqa Irinsfss Bvkafqgk Cracow Poland
Hhsxonjr Vjfx dtevkxip Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
09.06.2020
Italy Italy
Not recruiting
09.06.2020
Poland Poland
Not recruiting
09.06.2020
Spain Spain
Not recruiting
09.06.2020
The Netherlands The Netherlands
Not recruiting
09.06.2020

Trial locations

Investigated drugs:

DCC-3014 is an investigational medication being studied for its safety and effectiveness in treating patients with advanced tumors and tenosynovial giant cell tumor (TGCT). The trial aims to understand how the body processes this medication and to find the most suitable dose for future studies. Researchers are also looking at how well DCC-3014 works in shrinking or controlling the tumors.

Advanced Tumors – Advanced tumors refer to cancerous growths that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These tumors can affect various organs and tissues, leading to a range of symptoms depending on their location and size. As they grow, they may invade nearby structures and disrupt normal bodily functions. The progression of advanced tumors can vary widely, with some growing slowly over time, while others may spread rapidly. The impact on the body can be significant, often causing pain, fatigue, and other systemic effects.

Tenosynovial Giant Cell Tumor – Tenosynovial giant cell tumor is a rare, typically benign tumor that arises in the synovial lining of joints, tendons, or bursae. It is characterized by the proliferation of synovial-like cells, leading to swelling and pain in the affected area. The tumor can be localized or diffuse, with the localized form often presenting as a single mass, while the diffuse form can involve larger areas. Over time, the tumor may cause joint stiffness and reduced mobility due to its growth and pressure on surrounding tissues. Although it is generally non-cancerous, it can cause significant discomfort and functional impairment.

Trial ID:
2024-514933-39-00
Protocol code:
DCC-3014-01-001
NCT ID:
NCT03069469
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

Other Trials to Consider

  • A Phase I/II Study of GVV858 Alone or in Drug Combination for Patients with Advanced Hormone Receptor‑Positive, HER2‑Negative Breast Cancer

    Recruiting

    2 1 1 1
    Czechia Denmark France Germany Italy Spain
  • A study of PM54 and pembrolizumab in adults with advanced cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain