Clinical Trials /

A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

NCT02564198

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 15542
  • SECONDARY ID: I4T-MC-JVDA
  • SECONDARY ID: ADVL1416
  • NCT ID: NCT02564198

Conditions

  • Pediatric Solid Tumor
  • Refractory Tumor
  • Recurrent Tumor
  • CNS Malignancies

Interventions

DrugSynonymsArms
RamucirumabLY3009806, IMC-1121B, CyramzaRamucirumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RamucirumabExperimental(Part A-Non-CNS Solid Tumors) Escalating doses of ramucirumab given intravenously (IV) every other week over a 6-week cycle. Participants may continue treatment until discontinuation criteria are met. (Part B-CNS Tumors) Maximum tolerated dose and/or recommended Phase 2 Dose (RP2D) determined from Part A of ramucirumab given IV every other week over a 6-week cycle. Participants may continue treatment until discontinuation criteria are met.
  • Ramucirumab

Eligibility Criteria

        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
      
Maximum Eligible Age:21 Years
Minimum Eligible Age:12 Months
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose of Ramucirumab
Time Frame:Baseline to Study Completion (Approximately 42 Months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD): Best Overall Response (BOR)
Time Frame:Baseline to Date of Objective Disease Progression (Approximately 42 Months)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • relapsed pediatric solid tumors
  • unspecified childhood solid tumor
  • brain and central nervous system tumors

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