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RecruitingPHASE2INTERVENTIONAL

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

This research programme, called a 'master protocol', is designed to test several new medicines for treating different types of cancer in children and young adults aged 1 to 39. The main goal is to find better and safer treatments. Instead of organising many separate trials, this master protocol allows researchers to test different drugs more efficiently. As new potential medicines emerge for various cancers, they can be added to this programme. The study will look at medicines like Ramucirumab, Cyclophosphamide, and others. Taking part means helping doctors understand which treatments work best for young people with cancer, potentially improving future care.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Eli Lilly and Company
Enrolment target
105
Start
22 Jan 2020
Estimated completion
01 May 2027

What is this study about?

This research programme is designed to find better ways to treat cancer in children and young adults. It’s like an umbrella for many smaller studies, all looking at different new medicines. Scientists call this a 'master protocol' because it helps them manage lots of studies more efficiently. Each smaller study within this programme will test a specific new drug or combination of drugs against certain types of cancer.

The main aim is to discover which new treatments are effective and safe for young people. As new drugs are developed, they can be easily added to this ongoing research. This means the programme can adapt and explore the most promising treatments as they become available.

By taking part, you would be helping doctors and researchers understand more about cancer in young people and how best to treat it. The information gained from these studies could lead to new and improved treatments for future patients.

Key takeaways

  • This is a large research programme exploring new cancer treatments.
  • It's for children and young adults aged 1 to 39.
  • It aims to find better and safer medicines for various cancers.
  • Many different new drugs will be tested over time.
  • Participants help advance understanding of cancer treatments.
  • Your health would be closely monitored throughout.

Who may be eligible?

To join this study, participants generally need to have cancer that can be measured or observed using standard medical tests. Your doctor will also check your general health and how well you can do your usual activities. This is often measured using special scores called Lansky (for younger children) or Karnofsky (for older teens and young adults).

You must have finished any previous cancer treatments at least 7 days before starting this study and have recovered from any significant side effects. Your blood tests and organ function (like kidneys and liver) need to be working well.

There are also some reasons why you might not be able to join. For example, if you have other serious health conditions, active infections, or have recently had a bone marrow or organ transplant. Females who are pregnant or breastfeeding cannot take part. Also, if you are able to have children, you would need to agree to use effective birth control during the study and for some time afterwards.

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.

  1. Are you between 1 and 39 years old?
  2. Do you have a type of cancer that doctors can measure or observe?
  3. Have you finished any recent cancer treatments and recovered from side effects?
  4. Are your blood tests and organ functions generally healthy?
  5. If female, are you not pregnant or breastfeeding, and willing to use birth control if needed?
  6. If male, are you willing to use birth control if needed?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for check-ups and to receive the study medication. Doctors and nurses would closely monitor your health and any side effects. You would likely have blood tests, scans, and other assessments to see how the treatment is working and to ensure your safety. The specific types of visits and tests would depend on the particular drug you are receiving and your individual situation. You would continue in the study for as long as the treatment is helping, and follow-up appointments would check on your health even after the main treatment period.

Potential risks and benefits

Participating in this trial offers the potential benefit of accessing new treatments that are not yet widely available, which may be more effective than standard options. You would also contribute valuable information that could help many other young people with cancer in the future. However, there are potential risks, as these are new medicines, and they may have side effects that are not yet fully known. Any side effects you experience will be carefully monitored. You have the right to withdraw from the study at any time without needing to give a reason, and your medical care will not be affected.

Locations (73)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Childrens Hospital of Alabama
    Verified postcode
    Birmingham, United States· Not yet recruiting
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Phoenix Children's Hospital
    Verified postcode
    Phoenix, United States· Recruiting
  • Childrens Hospital of Los Angeles
    Verified postcode
    Los Angeles, United States· Completed
  • UCLA Medical Center
    Verified postcode
    Los Angeles, United States· Not yet recruiting
  • Children's Hospital of Orange County
    Verified postcode
    Orange, United States· Recruiting
  • Children's Hospital of Colorado
    Verified postcode
    Denver, United States· Recruiting
  • Children's National Medical Center
    Verified postcode
    Washington D.C., United States· Recruiting
  • Golisano Children's Hospital of Southwest Florida
    Verified postcode
    Fort Myers, United States· Recruiting
  • Mayo Clinic in Florida
    Verified postcode
    Jacksonville, United States· Recruiting
  • Children's Healthcare of Atlanta, Inc. at Egleston
    Verified postcode
    Atlanta, United States· Not yet recruiting
  • Ann & Robert H Lurie Children's Hospital of Chicago
    Verified postcode
    Chicago, United States· Recruiting

Common questions

What is a 'master protocol'?

It's like an umbrella research plan that covers many smaller studies, making it easier to test different new cancer medicines for young people.

Who can take part in this study?

Children and young adults aged 1 to 39 years with certain types of cancer, who are generally healthy enough and meet specific medical criteria.

Will I know which drug I'm getting?

Yes, your doctor will discuss with you and your family which specific drug within this research programme is being considered for your treatment.

What happens if the treatment doesn't work?

Your doctors will regularly check how well the treatment is working. If it's not helping, they will discuss other treatment options with you and your family.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point. Your decision will not affect 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?

Register your interest

Share your details and the research team for "A Master Protocol (LY900023) That Includes Several Clinical …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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