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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Eli Lilly and Company
Sponsor:
Collaborator:
Children's Oncology Group
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02564198
First received: September 25, 2015
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Pediatric Solid Tumor
Refractory Tumor
Recurrent Tumor
CNS Malignancies
Drug: Ramucirumab
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 36
Study Start Date: December 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Ramucirumab
Administered IV
Other Names:
  • LY3009806
  • IMC-1121B
  • Cyramza

  Eligibility

Ages Eligible for Study:   12 Months to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02564198

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 21 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Children's Oncology Group
Investigators
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
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02564198     History of Changes
Other Study ID Numbers: 15542
I4T-MC-JVDA ( Other Identifier: Eli Lilly and Company )
ADVL1416 ( Other Identifier: Children's Oncology Group )
Study First Received: September 25, 2015
Last Updated: March 21, 2017

Keywords provided by Eli Lilly and Company:
relapsed pediatric solid tumors
unspecified childhood solid tumor
brain and central nervous system tumors

Additional relevant MeSH terms:
Neoplasms
Endothelial Growth Factors
Ramucirumab
Growth Substances
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on March 30, 2017