A Phase 1 Study Of Ramucirumab a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors Including CNS Tumors

Study on the Safety of an Investigational Medication in Children with Tumors that Have Returned

Recruiting
1 years - 21 years
All
Phase N/A
1 Location

Brief description of study.

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.

Detailed description of study

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.

Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cancer,Solid Tumor
  • Age: 1 years - 21 years
  • Gender: All

Inclusion Criteria
Part A: participants with recurrent or refractory non-CNS solid tumors
Part B: participants with recurrent or refractory CNS tumors
Measurable or evaluable disease
No other therapeutic options
Performance Status: Karnofsky ?50% for participants >16 years and Lansky ?50 for participants ?16 years
Exclusion Criteria
Active or recent history of serious bleeding events
Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses
Active or recent history of hypertensive crisis or hypertensive encephalopathy
Active non-healing wound or bone fracture
History of solid organ transplant

Updated on 19 Feb 2024. Study ID: 1511807264 (PHO-LILLY-CROOP-ADVL1416)

This study investigates the safety of an investigational medication in children who have solid tumors that have returned or are not responding to treatment. Solid tumors are abnormal masses of tissue that can occur in various parts of the body, including the brain and spinal cord, which are part of the central nervous system (CNS).

Participants in the study will receive the investigational medication. Their health will be closely monitored to observe any side effects or changes in their condition. This process is important to ensure the safety of the medication for children with these types of tumors.

  • Who can participate: Children with recurrent or refractory solid tumors, including CNS tumors, can participate. They must have measurable or evaluable disease and no other treatment options. Participants must have a performance status of at least 50% on the Karnofsky or Lansky scale, depending on age.
  • Study details: Participants will receive an investigational medication. A placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine, is not mentioned in this study.

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