RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

This study is for children and young adults (up to 30 years old) who have solid cancers that have returned or not responded to earlier treatments, including specific types like Ewing sarcoma. It's testing two new combinations of medicines: Onivyde with talazoparib, or Onivyde with temozolomide. Both combinations aim to damage cancer cells and stop them from repairing themselves. The first part of the study (Phase 1) will find the safest and most effective dose for these drug combinations. After that, more patients will be invited to join expansion groups to see how well these doses work. A separate part of the study (Phase 2) will specifically focus on young people with Ewing sarcoma, comparing how well both drug combinations work for them.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

St. Jude Children's Research Hospital

Enrolment target

Start

09 Jun 2021

Estimated completion

31 Dec 2026

What is this study about?

This research study, called ONITT, is for children and young adults (between 1 and 30 years old) who have solid cancers that have returned after treatment, or haven't fully responded to previous treatments. This includes many different types of solid tumours, with a special focus on Ewing sarcoma.

The study is looking at two new combinations of medicines. Both combinations include a drug called Onivyde. One combination is Onivyde with talazoparib, and the other is Onivyde with temozolomide. These drugs work by damaging the cancer cells' DNA and stopping them from fixing themselves, which can make the cancer cells die. The main goal is to find out if these combinations are safe and if they can effectively fight the cancer.

The study has two main parts. The first part (Phase 1) involves a small number of patients and aims to find the right amount (dose) of each drug combination that is safe and can be tolerated. Once these doses are found, the study moves into 'expansion phases' where more patients will receive these specific doses to see how well the treatment works against their cancer. There will also be a separate part of the study (Phase 2) specifically for young people with Ewing sarcoma, comparing how well the two drug combinations work for this particular cancer.

Key takeaways

The study tests two new drug combinations for tough-to-treat solid cancers in young people.
It aims to find the safest and most effective doses of these treatments.
It includes a special focus on Ewing sarcoma.
Both drug combinations work by damaging cancer cells and stopping them from repairing themselves.
Participation involves regular hospital visits for checks and scans.

Who may be eligible?

This study is looking for children and young adults aged between 1 and 30 years old. You might be able to take part if you have a solid cancer (not a brain or spinal cord tumour) that has come back after treatment, or if the initial treatment didn't get rid of it completely. Doctors will need to have confirmed your cancer diagnosis.

For some parts of the study, especially if you have Ewing sarcoma, your doctors will check if your cancer has specific genetic markers that mean it might respond well to these treatments. Your general health and how well you can move around will also be checked to make sure you're well enough to take part.

The study has specific criteria for different cancer types and stages. It's really important to talk to your doctor about whether this study is right for you, as they will check all the detailed requirements.

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 between 1 and 30 years old?
Do you have a solid cancer (not a brain or spinal cord tumour) that has come back or not responded to previous treatment?
Has your doctor confirmed your cancer diagnosis?
Are you generally well enough to take part in a study?
For Ewing sarcoma, are you okay with genetic checks for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be assigned by chance (like flipping a coin) to receive one of the two drug combinations: Onivyde with talazoparib, or Onivyde with temozolomide. During the first part of the study, the medical team will carefully monitor you to find the best and safest dose of these medicines. This will involve regular visits to the hospital for check-ups, blood tests, and scans to see how the treatment is affecting your cancer and your body.

Once the safest doses are found, more patients will join the study. If you have Ewing sarcoma, you'll also be assigned by chance to one of the two drug combinations, given at the best doses. You'll continue to have regular check-ups, blood tests, and scans to see if the treatment is helping your cancer. The length of time you'll be on the study will depend on how you respond to the treatment, but you will have regular follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study is that you might gain access to new treatments that aren't widely available yet, which could help fight your cancer. However, there's no guarantee the treatment will work for everyone, and it might not work for you. There are potential risks from the medications, such as side effects, which the doctors will monitor closely and explain to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Lucille Packard Children's Hospital Stanford
Verified postcode
Palo Alto, United States· Recruiting
Children's Hospital Colorado
Verified postcode
Aurora, United States· Recruiting
Children's National Medical Center
Verified postcode
Washington D.C., United States· Recruiting
Children's Healthcare of Atlanta/Emory University School of Medicine
Verified postcode
Atlanta, United States· Recruiting
Children's Hospital and Clinics of Minn
Verified postcode
Minneapolis, United States· Recruiting
St. Jude Children's Research Hospital
Verified postcode
Memphis, United States· Recruiting
Texas Children's Hospital/ Baylor College of Medicine
Verified postcode
Houston, United States· Active not recruiting
The Hospital for Sick Children
Verified postcode
Toronto, Canada· Recruiting
CHU Sainte-Justine
Verified postcode
Montreal, Canada· Recruiting
BC Children's Hospital Research Institute
Verified postcode
Vancouver, Canada· Not yet recruiting

Common questions

What kind of cancers is this study for?

This study is for children and young adults with various solid cancers that have come back or not responded to previous treatments, including some specific types like Ewing sarcoma.

What's the main goal of this study?

The main goal is to find the safest and most effective doses of two new drug combinations for these cancers, and then to see how well they work.

How will I know which treatment I'll get?

You'll be assigned by chance (like drawing lots) to receive one of the two drug combinations being tested.

How long will I be in the study?

The length of your participation will depend on how you respond to the treatment, but you'll have regular hospital visits and follow-up care.

Can I stop being part of the study if I want to?

Yes, you can choose to leave the study at any time, and this won't affect your regular medical care.

How to find out more

Sara Federico, MD

referralinfo@stjude.org 888-226-4343 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.