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

This study is currently recruiting participants.
Verified May 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02564198
First Posted: September 30, 2015
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Eli Lilly and Company
September 25, 2015
September 30, 2015
May 19, 2017
December 2015
January 2019   (Final data collection date for primary outcome measure)
  • Maximum Tolerated Dose of Ramucirumab [ Time Frame: Baseline to Study Completion (Approximately 42 Months) ]
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months) ]
  • Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months) ]
Same as current
Complete list of historical versions of study NCT02564198 on ClinicalTrials.gov Archive Site
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) ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pediatric Solid Tumor
  • Refractory Tumor
  • Recurrent Tumor
  • CNS Malignancies
Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza
Experimental: Ramucirumab

(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.

Intervention: Drug: Ramucirumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
January 2019
January 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Months to 21 Years   (Child, Adult)
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States
 
 
NCT02564198
15542
I4T-MC-JVDA ( Other Identifier: Eli Lilly and Company )
ADVL1416 ( Other Identifier: Children's Oncology Group )
No
Not Provided
Not Provided
Eli Lilly and Company
Eli Lilly and Company
Children's Oncology Group
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP