TriangleNCT02564198 · CITED IN SOURCE DOCUMENTS
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE1
- Status at capture
- COMPLETED
- Registry last update
- 2021-08-17
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Number of Participants With Anti-Ramucirumab Antibodies
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
Duration of Response (DOR)
Overall Survival
Adverse events
Limitations, agreements, and source contact
Who could take part
- 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
- healthy Volunteers
- false
- maximum Age
- 21 Years
- minimum Age
- 12 Months
- sex
- ALL
- std Ages
- CHILD
- ADULT
Treatment arms and interventions
- arm Groups
- description
- (Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle. (Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle.
- intervention Names
- Drug: Ramucirumab
- label
- Ramucirumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Ramucirumab
- description
- Administered IV
- name
- Ramucirumab
- other Names
- LY3009806
- IMC-1121B
- Cyramza
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 29
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab
- time Frame
- Baseline to Study Completion (Up to 42 Months)
- description
- Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.
- measure
- Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
- time Frame
- Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
- description
- 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.
- measure
- Number of Participants With Anti-Ramucirumab Antibodies
- time Frame
- Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)
- secondary Outcomes
- description
- 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.
- measure
- Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
- time Frame
- Baseline to Date of Objective Disease Progression (Up to 42 Months)
- description
- 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.
- measure
- Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
- time Frame
- Baseline to Date of Objective Disease Progression (Up to 42 Months)
- description
- 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.
- measure
- Duration of Response (DOR)
- time Frame
- 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)
- description
- 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.
- measure
- Overall Survival
- time Frame
- Baseline to Date of Death from Any Cause (Up to 42 Months)
Full 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.
Source references
- see Also Links
- label
- Click here for more information about this study: A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-e3b98a5b444955bfb789
- requested nct id
- NCT02564198
- primary nct id
- NCT02564198
- source kind
- fda_spl_label
- source record id
- 161cb5e7-7955-45e5-bdde-9be94fdbe76a
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- payload sha256
- 797555c0dfeadd8fe159bf8b4e66ee26f9885c1144b07a9335b5d2a246b69973
- payload
- application numbers
- BLA125477
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-e3b98a5b444955bfb789
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02564198
- occurrences
- context exact
- c patients have not been established. The safety and effectiveness of CYRAMZA were assessed but not established in a single-arm, multicenter, open-label trial [NCT02564198] that included 23 pediatric patients aged 1 year to <17 years with relapsed or refractory solid tumors who received CYRAMZA as a single agent and two multicent
- end
- 2990
- exact text
- NCT02564198
- start
- 2979
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00000.json
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- source json pointer
- /results/72/use_in_specific_populations/0
- source kind
- fda_spl_label
- source record id
- 161cb5e7-7955-45e5-bdde-9be94fdbe76a
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- c3ae2fee1884a4ae7df8be2bf2bddc883bd4e79131c14b0f502f4915991a1a23
- spl effective time
- 20260609
- spl set id
- c6080942-dee6-423e-b688-1272c2ae90d4
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-ec8d899b9ab81782994e
- requested nct id
- NCT02564198
- primary nct id
- NCT02564198
- source kind
- fda_spl_label
- source record id
- 161cb5e7-7955-45e5-bdde-9be94fdbe76a
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- payload sha256
- 105ed92a9f6918eb59ada4349000150e2425d3a9f3cc21a51429218c6a975dd5
- payload
- application numbers
- BLA125477
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-ec8d899b9ab81782994e
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT02564198
- occurrences
- context exact
- c patients have not been established. The safety and effectiveness of CYRAMZA were assessed but not established in a single-arm, multicenter, open-label trial [NCT02564198] that included 23 pediatric patients aged 1 year to <17 years with relapsed or refractory solid tumors who received CYRAMZA as a single agent and two multicent
- end
- 240
- exact text
- NCT02564198
- start
- 229
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00000.json
- source file sha256
- 0dba7a040bbbf460aa9f482c5b67c9f28f75fc9df775ee1e7b345b758f780e07
- source json pointer
- /results/72/pediatric_use/0
- source kind
- fda_spl_label
- source record id
- 161cb5e7-7955-45e5-bdde-9be94fdbe76a
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 384954fdda3db85203e19ee6edb268915c0f2d43b0d56151f28d9c24ed52d965
- spl effective time
- 20260609
- spl set id
- c6080942-dee6-423e-b688-1272c2ae90d4
Preserved source evidence · Not medical advice