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

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ClinicalTrials.gov Identifier: NCT02564198
Recruitment Status : Recruiting
First Posted : September 30, 2015
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pediatric Solid Tumor Refractory Tumor Recurrent Tumor CNS Malignancies Drug: Ramucirumab Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : December 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ramucirumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose of Ramucirumab [ Time Frame: Baseline to Study Completion (Approximately 42 Months) ]
  2. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months) ]
  3. Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months) ]

Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 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