Clinical trial NCT02564198: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric Solid Tumor
Refractory Tumor
Recurrent Tumor
CNS Malignancies
Keywords: relapsed pediatric solid tumors
unspecified childhood solid tumor
brain and central nervous system tumors
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Children's Oncology Group
First posted: 2015-09-30
Enrollment: 29
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
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)
measure: Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
timeFrame: Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
measure: Number of Participants With Anti-Ramucirumab Antibodies
timeFrame: Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
Secondary outcomes:
measure: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline to Date of Objective Disease Progression (Up to 42 Months)
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
timeFrame: Baseline to Date of Objective Disease Progression (Up to 42 Months)
measure: Duration of Response (DOR)
timeFrame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 42 Months)
measure: Overall Survival
timeFrame: Baseline to Date of Death from Any Cause (Up to 42 Months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Childrens Hospital of Alabama
state: Alabama
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Scottish Rite
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Bethesda
country: United States
facility: Mark O Harfield-Warren Grant Magnuson Clinical Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: St Jude Childrens Research Hospital
state: Tennessee
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Foundation
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: