Not recruiting

Study on the Safety and Effectiveness of MK-1200 for Patients with Advanced Solid Tumors

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called MK-1200 for people with advanced solid tumors. These tumors include types of cancer such as gastric cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. The study aims to understand how safe and tolerable MK-1200 is when used alone. The treatment is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

Participants in the study will receive MK-1200 and will be monitored for any side effects or adverse reactions. The study will also compare the effects of MK-1200 with other treatments, including antiemetics and antinauseants, antipruritics, corticosteroids, and other analgesics and antipyretics, which are used to manage symptoms like nausea, itching, inflammation, and pain. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of MK-1200.

The trial is divided into two parts, and participants will be closely observed throughout the study to ensure their safety. Researchers will collect data on how the body responds to MK-1200, including how long the treatment remains effective and how it affects the progression of the disease. The study is expected to continue for several years, allowing researchers to gather comprehensive information on the potential benefits and risks of MK-1200 for treating advanced solid tumors.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will be informed about the trial's purpose, which is to evaluate the safety and effectiveness of MK-1200 in individuals with advanced solid tumors.
The participant will be required to provide informed consent, acknowledging their understanding of the study and its potential risks and benefits.
Step 2
Initial assessment
An initial assessment will be conducted to confirm the participant's eligibility. This includes verifying the presence of an advanced solid tumor, such as gastric, esophageal, biliary tract, or pancreatic ductal adenocarcinoma.
The participant's medical history will be reviewed, and any adverse effects from previous cancer treatments must have resolved to a mild level or baseline.
Step 3
Treatment administration
The participant will receive MK-1200 through an intravenous infusion. The dosage and frequency will be determined by the study protocol and the participant's specific condition.
The treatment will continue as per the study schedule, with regular monitoring to assess the participant's response and any side effects.
Step 4
Monitoring and follow-up
Throughout the study, the participant will undergo regular check-ups to monitor their health and the effectiveness of the treatment.
The study will track various outcomes, including the number of participants experiencing side effects, the response rate to the treatment, and overall survival rates.
Step 5
Completion of the study
The study is expected to conclude by March 2027. Upon completion, the participant will have a final assessment to evaluate their overall health and any long-term effects of the treatment.
The results of the study will contribute to understanding the safety and efficacy of MK-1200 for treating advanced solid tumors.

Who can join the trial?

5 criteria

You must have a confirmed diagnosis of an advanced solid tumor. This means a type of cancer that has spread and cannot be removed by surgery. The specific types of cancer include gastric cancer (stomach cancer), esophageal cancer (cancer of the tube that connects the throat to the stomach), biliary tract cancer (cancer in the bile ducts), or pancreatic ductal adenocarcinoma (a type of pancreatic cancer).
If you had side effects from previous cancer treatments, these side effects must have improved to a mild level or returned to what they were before treatment.
If you are infected with the human immunodeficiency virus (HIV), your HIV must be well controlled with medication.
You must have received and your cancer must have worsened after 1 or 2 previous treatments.
Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have an advanced solid tumor cannot participate. An advanced solid tumor is a type of cancer that has spread and formed a mass in the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not excluded. A vulnerable population includes groups that may need special protection, like children or the elderly.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Verified
Naples, Italy
Centr Georges Francois Leclerc
Verified
Dijon, France
Centre Hospitalier Universitaire De Nantes
Verified
Nantes, France

Trial locations

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Investigated drugs

MK-1200 is an investigational medication being studied for its safety and effectiveness in treating advanced solid tumors. This trial aims to understand how well patients tolerate the medication and to identify any potential side effects. The study is conducted in two parts, focusing on the safety and tolerability of MK-1200 when used alone.

Mk-1200

What is already known about the treatment

MK-1200 – This medication is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating advanced solid tumors. It is in the early stages of research, specifically in Phase 1/2 trials, and is not yet widely recognized in medical literature. The main therapeutic indication for MK-1200 is the treatment of advanced solid tumors. At the molecular level, MK-1200 works by targeting specific pathways that are involved in tumor growth and survival, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational anti-cancer agent.

Investigated diseases

Advanced Solid Tumor – Advanced solid tumors are a group of cancers that originate in solid organs or tissues, such as the breast, lung, or colon, and have progressed to a more severe stage. These tumors are characterized by their ability to grow uncontrollably and invade nearby tissues. As they advance, they may spread to other parts of the body, a process known as metastasis. The progression of these tumors can lead to various symptoms depending on their location and size, such as pain, swelling, or organ dysfunction. The growth and spread of these tumors can significantly impact the body's normal functions. Understanding the behavior of advanced solid tumors is crucial for developing effective management strategies.