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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02564198
Other study ID # 15542
Secondary ID I4T-MC-JVDAADVL1
Status Completed
Phase Phase 1
First received
Last updated
Start date December 11, 2015
Est. completion date July 16, 2019

Study information

Verified date July 2021
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date July 16, 2019
Est. primary completion date July 16, 2019
Accepts healthy volunteers No
Gender All
Age group 12 Months to 21 Years
Eligibility 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

Study Design


Intervention

Drug:
Ramucirumab
Administered IV

Locations

Country Name City State
United States University of Michigan Health Systems Ann Arbor Michigan
United States Children's Healthcare of Atlanta at Scottish Rite Atlanta Georgia
United States Mark O Harfield-Warren Grant Magnuson Clinical Center Bethesda Maryland
United States Childrens Hospital of Alabama Birmingham Alabama
United States Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois
United States Children's Hospital Medical Center Cincinnati Ohio
United States Texas Childrens Hospital Houston Texas
United States Riley Hospital for Children Indianapolis Indiana
United States St Jude Childrens Research Hospital Memphis Tennessee
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Hospital Minneapolis Minnesota
United States Children's Oncology Group Monrovia California
United States Columbia University Medical Center New York New York
United States Childrens Hospital of Orange County Orange California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Childrens Hospital of Pittsburgh Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Washington University Medical School Saint Louis Missouri
United States University of California, San Francisco San Francisco California
United States Seattle Children's Hospital Research Foundation Seattle Washington
United States Children's National Medical Center Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
Eli Lilly and Company Children's Oncology Group

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab A DLT is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria, graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0:
1. Any death not clearly due to the underlying disease or extraneous causes 2. Neutropenic fever 2. Any Grade =3 non-hematologic toxicity 3. Grade =4 neutropenia or thrombocytopenia >7 days 4. Grade =3 thrombocytopenia with bleeding 5. Grade =3 nausea/vomiting or diarrhea>72 hours with adequate antiemetic and other supportive care 6. Grade =3 fatigue =1 week 7. Grade =3 electrolyte abnormality that lasts>72 hours, unless the Participant has clinical symptoms, in which case all Grade 3+electrolyte abnormality regardless of duration should count as a DLT.
8. Grade =3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
Baseline to Study Completion (Up to 42 Months)
Primary Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab. Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
Primary Number of Participants With Anti-Ramucirumab Antibodies Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
Secondary Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Baseline to Date of Objective Disease Progression (Up to 42 Months)
Secondary Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Baseline to Date of Objective Disease Progression (Up to 42 Months)
Secondary Duration of Response (DOR) DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. 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)
Secondary Overall Survival Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date. Baseline to Date of Death from Any Cause (Up to 42 Months)
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