Phase 1
Completed N=29
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Pediatric Solid Tumor · Refractory Tumor · Recurrent Tumor · CNS Malignancies
Source: ClinicalTrials.gov NCT02564198 ↗
Enrolled (actual)
29
Serious AEs
41.4%
Results posted
Aug 2021
Primary outcomePrimary: Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab — 1; 1 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab |
1; 1 | — |
| PRIMARY Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab |
30.0; 48.3; 53.6; 80.2 | — |
| PRIMARY Number of Participants With Anti-Ramucirumab Antibodies |
0; 0; 0 | — |
| SECONDARY Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) |
62.5; 40.0; 33.3 | — |
| SECONDARY Duration of Response (DOR) |
— | — |
| SECONDARY Overall Survival |
NA; NA; NA | — |
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
Data sourced from ClinicalTrials.gov (NCT02564198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.