A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This medical study is exploring a new treatment called R-DXd for women with advanced ovarian, primary peritoneal, or fallopian tube cancer. These are cancers that haven't responded well to standard platinum-based chemotherapy. The study has two main parts. The first part (Phase 2) will help researchers find the best and safest dose of R-DXd. Once that's decided, the second part (Phase 3) will compare R-DXd with other existing chemotherapy treatments to see how well it works and if it's better. The goal is to see if R-DXd can be a new helpful option for these specific cancers, focusing on how safe it is and how well it helps control the disease.
At a glance
What is this study about?
This medical study is focusing on a new treatment called R-DXd for certain types of cancer found in the ovary, the lining of the abdomen (primary peritoneal cancer), or the fallopian tubes. These cancers are considered 'high-grade,' which means they tend to grow quickly. Importantly, this study is for people whose cancer has unfortunately not responded well to, or has come back after, platinum-based chemotherapy, a common treatment.
R-DXd is a special type of medicine. It's like a guided missile that targets cancer cells specifically. It has two parts: an antibody that finds a specific tag (called CDH6) on the cancer cells, and a chemotherapy drug attached to it. This design means the chemotherapy is delivered directly to the cancer cells, hopefully causing fewer side effects to healthy cells. The study wants to see how well this targeted treatment works and if it's a safe option for people with these specific cancers.
The study is being carried out in two main stages. The first stage (called Phase 2) will involve a smaller group of people and will help doctors figure out the best amount (dose) of R-DXd to give. They'll be looking carefully at how safe it is and if it shows early signs of helping. Once the best dose is found, the study will move to the second, larger stage (called Phase 3). In this stage, R-DXd will be compared to other standard chemotherapy treatments available. This will help confirm if R-DXd is an effective and safe new treatment option for people facing these challenging cancers.
Key takeaways
- This study is for ovarian, primary peritoneal, or fallopian tube cancer that hasn't responded to platinum chemotherapy.
- It's testing a new targeted drug called R-DXd.
- The study has two parts: finding the right dose and then comparing it to existing treatments.
- Participation involves regular clinic visits, tests, and potentially biopsies.
- It aims to find new, effective, and safe treatment options.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you must be at least 18 years old. You need to have a confirmed diagnosis of high-grade ovarian, primary peritoneal, or fallopian tube cancer. Your cancer must also be considered 'platinum-resistant,' meaning it has grown despite or shortly after receiving platinum-based chemotherapy.
For the first part of the study, you'll need to have had between one and three previous rounds of cancer treatment. For the second, larger part, you could have had up to four previous rounds of treatment. Also, for the first part, doctors will need to take a small tissue sample (biopsy) of your cancer before and during the study to learn more about it, unless a recent sample is available.
There are also some other specific health requirements that the study doctors will check to make sure the treatment is as safe as possible for you. It's important to discuss your complete medical history with the study team to see if you fit all the criteria.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have high-grade ovarian, primary peritoneal, or fallopian tube cancer?
- Has your cancer been described as 'platinum-resistant'?
- Have you had at least 1, but no more than 4, previous lines of cancer treatment?
- Are you willing to have regular medical checks and potentially a biopsy?
- Your doctor can confirm if you meet other specific health requirements.
What does participation involve?
If you join this study, you will receive the study medication, R-DXd, or one of the other standard chemotherapy drugs (paclitaxel, topotecan, or PLD), depending on which group you are in. You will have regular visits to the clinic for treatments, check-ups, and tests like blood tests and scans, to monitor your health and how the treatment is working. For people in the first part of the study, a small tissue sample (biopsy) will be taken before and during treatment. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be monitored carefully throughout. You are free to withdraw from the study at any time.
Potential risks and benefits
Locations (146)
- Alaska Women's Cancer CareVerified postcodeAnchorage, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Recruiting
- Sylvester Comprehensive Cancer Center at LennarVerified postcodeCoral Gables, United States· Active not recruiting
- Sylvester Comprehensive Cancer Center at Deerfield BeachVerified postcodeDeerfield Beach, United States· Active not recruiting
- Florida Cancer SpecialistsVerified postcodeLake Mary, United States· Recruiting
- Sylvester Cancer CenterVerified postcodeMiami, United States· Recruiting
- Mount Sinai Comprehensive Cancer CenterVerified postcodeMiami Beach, United States· Recruiting
- Sylvester Comprehensive Cancer Center at PlantationVerified postcodePlantation, United States· Active not recruiting
- Community MD Anderson Cancer Center- EastVerified postcodeIndianapolis, United States· Active not recruiting
- Community MD Anderson Cancer Center- SouthVerified postcodeIndianapolis, United States· Active not recruiting
- Community Health Network - MD AndersonVerified postcodeIndianapolis, United States· Recruiting
- St. Elizabeth Medical CenterVerified postcodeEdgewood, United States· Recruiting
Common questions
What is R-DXd?
R-DXd is a new type of drug that combines an antibody (a protein that finds specific cancer markers) with a chemotherapy medicine. It's designed to deliver treatment directly to cancer cells.
What does 'platinum-resistant' mean?
This means your cancer has started to grow again or did not shrink while you were receiving treatment with platinum-based chemotherapy drugs, which are common treatments for these cancers.
Will I definitely get the new R-DXd drug?
In the second part of the study, some people will receive R-DXd, while others will receive one of the standard chemotherapy treatments. This comparison helps doctors understand how well the new drug works.
What kind of tests will I have if I join?
You will have regular examinations, blood tests, and scans to see how your body is reacting to the treatment and if your cancer is responding. For some, biopsies will also be needed.
Can I stop participating in the study at any time?
Yes, absolutely. Participation is completely voluntary, and you can decide to leave the study at any point without needing a reason, and it won't affect your future medical care.
How to find out more
Medical Director Contact for Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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