A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
This study is looking into a new experimental medicine called Sofetabart Mipitecan for people with certain types of ovarian, fallopian tube, or peritoneal cancers. It's split into two main groups. One group includes patients whose cancer is no longer responding well to a common type of chemotherapy called platinum-based treatment (Part A). The other group includes patients whose cancer still responds to these platinum treatments (Part B). The main goal of the study is to find out if Sofetabart Mipitecan is more effective than the standard treatments currently used by doctors for these cancers. Researchers also want to understand how safe this new medicine is and what side effects it might cause. Your time in the study would depend on how your cancer responds to the treatment.
At a glance
What is this study about?
This important study is investigating a new medication called Sofetabart Mipitecan, which could potentially offer a new treatment option for certain types of ovarian, fallopian tube, and peritoneal cancers. These are cancers that start in the ovaries, fallopian tubes, or the lining of the abdomen. The study is divided into two parts to look at different situations people might be in regarding their cancer treatment history.
Part A of the study is for individuals whose cancer has stopped responding effectively to platinum-based chemotherapy. These are treatments commonly used for these types of cancers, and when they stop working, doctors look for other options. Part B is for people whose cancer has responded well to platinum-based chemotherapy in the past, but has since come back.
The researchers want to compare Sofetabart Mipitecan to existing standard treatments to see if it works better at controlling the cancer. They will also carefully monitor participants to understand the medicine's safety, including any side effects. The information gathered from this study will help determine if Sofetabart Mipitecan could become a new approved treatment to help more people.
Key takeaways
- This study evaluates a new cancer medicine, Sofetabart Mipitecan.
- It's for specific ovarian, fallopian tube, and peritoneal cancers.
- It aims to see if the new medicine is better and safer than current treatments.
- The study includes those with platinum-resistant and platinum-sensitive cancers.
- Participation involves regular hospital visits for treatment and monitoring.
Who may be eligible?
To join this study, your doctor would need to confirm that you have a specific type of ovarian, fallopian tube, or peritoneal cancer, and that samples of your tumour tissue are available for review. Your cancer must also have shown signs of getting worse since your last treatment. You should generally be well enough to carry out most of your normal daily activities without much difficulty, and your doctors must be able to measure your cancer on scans.
For Part A, if your cancer has stopped responding to platinum-based chemotherapy within six months of your last dose, and you've had between one and three previous rounds of chemotherapy (or up to four if one was mirvetuximab soravtansine), you might be suitable. You should also have had certain other treatments unless there's a good reason you couldn't.
For Part B, if your cancer responded to platinum-based chemotherapy for more than six months but has since come back, and you've had one or two previous rounds of chemotherapy, you might be eligible. This part also requires that you've previously used a PARP inhibitor medication, and your cancer has worsened while on it or within six months of stopping it. You wouldn't be able to join if you had a related type of treatment before, or if your cancer got worse very quickly after your first platinum-based chemotherapy, or if you have specific kidney protein issues.
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.
- Do I have a confirmed diagnosis of high-grade ovarian, fallopian tube, or peritoneal cancer?
- Has my cancer gotten worse since my last treatment?
- Am I generally well enough to do most daily activities (ECOG 0-1)?
- If my cancer resists platinum chemotherapy, has it been less than 6 months since my last platinum dose? (Part A)
- If my cancer has responded to platinum chemotherapy, has it been more than 6 months since my last platinum dose before it came back? (Part B)
What does participation involve?
If you decide to take part in this study, you will receive either the new medicine, Sofetabart Mipitecan, or one of the standard treatments currently used for your cancer. You'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. The frequency of visits will be outlined by the study team.
The treatment will continue as long as it is helping you and you are not experiencing severe side effects. The total duration of your participation in the study will depend on how your cancer responds to the treatment and your overall health, but the study team will provide more specific details. There will also be follow-up appointments after you stop the study treatment to continue monitoring your health.
Potential risks and benefits
Locations (259)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States· Not yet recruiting
- HonorHealthVerified postcodePhoenix, United States· Not yet recruiting
- Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical CenterVerified postcodeBurbank, United States· Not yet recruiting
- City of Hope, DuarteVerified postcodeDuarte, United States· Not yet recruiting
- Moores Cancer CenterVerified postcodeLa Jolla, United States· Not yet recruiting
- UCLA Hematology/Oncology - Westwood (Building 100)Verified postcodeLos Angeles, United States· Not yet recruiting
- Stanford Women's Cancer CenterVerified postcodePalo Alto, United States· Not yet recruiting
- Kaiser Permanente Zion Medical CenterVerified postcodeSan Diego, United States· Not yet recruiting
- Sansum ClinicVerified postcodeSanta Barbara, United States· Recruiting
- Kaiser PermanenteVerified postcodeVallejo, United States· Not yet recruiting
- Anschutz Cancer PavilionVerified postcodeAurora, United States· Not yet recruiting
- AdventHealth Medical Group - PorterVerified postcodeDenver, United States· Not yet recruiting
Common questions
What is Sofetabart Mipitecan?
It's an experimental medicine being tested in this study to see if it can treat certain ovarian, fallopian tube, and peritoneal cancers.
What does 'platinum-resistant' or 'platinum-sensitive' mean?
It refers to how your cancer has responded to a common type of chemotherapy called platinum-based treatment. 'Resistant' means it stopped working quickly, 'sensitive' means it worked well for a longer time.
Will I definitely get the new medicine?
Not necessarily. This study compares the new medicine to existing treatments, so you might receive either Sofetabart Mipitecan or one of the standard care options.
How long would I be in the study?
Your time in the study will depend on how your cancer responds to the treatment and your general health. The study team will give you more specific information.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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