Clinical trial · Interventional
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
NCT02564198CI-TRIAL-00053345completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Malignancies | Central Nervous System Neoplasm | PROBABILISTIC | 0.70 |
| Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
| Recurrent Tumor | Neoplasm | CURATED_BROADER | 0.78 |
| Refractory Tumor | Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ramucirumab
- description
- (Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle. (Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
- interventionNames
- Drug: Ramucirumab
Primary outcomes (3)
- measure
- Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
- timeFrame
- Baseline to Study Completion (Up to 42 Months)
- description
- A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0: 1\. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade ≥3 non-hematologic toxicity 3. Grade ≥4 neutropenia or thrombocytopenia \>7 days 4. Grade ≥3 thrombocytopenia with bleeding 5. Grade ≥3 nausea/vomiting or diarrhea\>72 hours with adequate antiemetic and other supportive care 6. Grade ≥3 fatigue ≥1 week 7. Grade ≥3 electrolyte abnormality that lasts\>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT. 8\. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.