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A Non-randomized Open-label Multi-center Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma

Investigating Safety and Feasibility of a Treatment Being Studied in Pediatric Patients with Recurrent or Refractory Solid Tumors or Lymphoma

Recruiting
1-21 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study investigates the safety and feasibility of an investigational medication for children with solid tumors or lymphoma that have come back or do not respond to standard treatments. Solid tumors are abnormal masses of tissue that can occur in any part of the body, and lymphoma is a type of cancer that affects the immune system. The study aims to see if the investigational medication can be a safe option for these patients.

Participants in the study will undergo various procedures to assess the effects of the investigational medication. These procedures may include physical exams, blood tests, and imaging tests like X-rays or MRIs. These tests help doctors understand how the body is responding to the treatment and ensure that it is safe for the participants.

  • Who can participate: Children aged 1 to 18 years with certain types of solid tumors such as neuroblastoma, osteosarcoma, rhabdomyosarcoma, or Ewing sarcoma, or lymphoma that do not respond to current treatments can participate. They must have good bone marrow, kidney, and liver function. Children with active infections or certain lung conditions cannot participate.
  • Study details: Participants will receive the investigational medication and will be monitored for safety and response to the treatment. Participant actions include undergoing physical exams, blood tests, and imaging tests like X-rays or MRIs to assess the effects of the treatment.
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Study details
    lymphoma

TX9402

19 February 2024

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