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

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

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-000364-30-Outside-EU/EEA
Enrollment
Unknown
Registered
2021-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Solid Tumor CNS Malignancies

Interventions

Trade Name: Cyramza Product Name: Ramucirumab Pharmaceutical Form: Infusion INN or Proposed INN: Ramucirumab CAS Number: 947687-13-0 Other descriptive name: RAMUCIRUMAB Concentration unit: Other Conce

Sponsors

Eli Lilly and Company
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Timepoint(s) of evaluation of this end point: 1. Baseline to Study Completion (Approximately 42 Months) 2. Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months) 3.Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months);Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 1. Maximum Tolerated Dose of Ramucirumab 2. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab 3. Number of Participants with Anti-Ramucirumab Antibodies—

Secondary

MeasureTime frame
Secondary end point(s): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD): Best Overall Response (BOR) ;Timepoint(s) of evaluation of this end point: Baseline to Date of Objective Disease Progression (Approximately 42 Months)—

Countries

United States

Contacts

Public ContactAvailable Mon - Fri 9 AM - 5 PM EST

Eli Lilly and Company

1877285 4559

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026