Trial · NCT02564198
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
NCT02564198, Phase 1, Completed, Eli Lilly and Company; results first posted 2021-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors. Trials, record NCT02564198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564198
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
- NCT number
- NCT02564198
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 29 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies
- Interventions
- Ramucirumab
- First posted
- 2015-09-30
- Last updated
- 2021-08-17
- Results first posted
- 2021-08-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab | Baseline to Study Completion (Up to 42 Months) | 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. |
| Primary | Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI) | Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab. |
| Primary | Number of Participants With Anti-Ramucirumab Antibodies | Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months) | 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. |
| Secondary | Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline to Date of Objective Disease Progression (Up to 42 Months) | 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. |
| Secondary | Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) | Baseline to Date of Objective Disease Progression (Up to 42 Months) | 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. |
| Secondary | Duration of Response (DOR) | 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) | 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. |
| Secondary | Overall Survival | Baseline to Date of Death from Any Cause (Up to 42 Months) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab | Baseline to Study Completion (Up to 42 Months) | All randomized participants from Part A, who received at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI) | All randomized participants who received at least one dose of study drug and had evaluable PK data. Per protocol, 12 mg/kg Ramucirumab PK data were reported per dose level combining Part A and B participants. | microgram per milliliter (µg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Anti-Ramucirumab Antibodies | Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months) | All randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline to Date of Objective Disease Progression (Up to 42 Months) | All randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR) | Baseline to Date of Objective Disease Progression (Up to 42 Months) | All randomized participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | 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) | Zero participants analyzed. Duration of response was not evaluable, as there were no participants with CR or PR. | ||
| SECONDARY | Overall Survival | Baseline to Date of Death from Any Cause (Up to 42 Months) | All randomized participants who received at least one dose of study drug. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab | 8 mg/kg Ramucirumab (Part A) | 1 | Participants | ||
| Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab | 12 mg/kg Ramucirumab (Part A) | 1 | Participants | ||
| Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | 8 mg/kg Ramucirumab | Cycle 1 Day 1 | 30.0 | Geometric Coefficient of Variation 32 | microgram per milliliter (µg/mL) |
| Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | 12 mg/kg Ramucirumab | Cycle 1 Day 1 | 48.3 | Geometric Coefficient of Variation 41 | microgram per milliliter (µg/mL) |
| Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | 8 mg/kg Ramucirumab | Cycle 1 Day 43 | 53.6 | Geometric Coefficient of Variation 31 | microgram per milliliter (µg/mL) |
| Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab | 12 mg/kg Ramucirumab | Cycle 1 Day 43 | 80.2 | Geometric Coefficient of Variation 44 | microgram per milliliter (µg/mL) |
| Number of Participants With Anti-Ramucirumab Antibodies | 8 mg/kg Ramucirumab (Part A) | 0 | participants | ||
| Number of Participants With Anti-Ramucirumab Antibodies | 12 mg/kg Ramucirumab (Part A) | 0 | participants | ||
| Number of Participants With Anti-Ramucirumab Antibodies | 12 mg/kg Ramucirumab (Part B) | 0 | participants | ||
| Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | 8 mg/kg Ramucirumab (Part A) | 0 | 95% Confidence Interval 0.0 to 41.0 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 8 mg/kg Ramucirumab (Part A) | 8 | |
| Overall Study | STARTED | 12 mg/kg Ramucirumab (Part A) | 15 | |
| Overall Study | STARTED | 12 mg/kg Ramucirumab (Part B) | 6 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 8 mg/kg Ramucirumab (Part A) | 8 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 12 mg/kg Ramucirumab (Part A) | 15 | |
| Overall Study | Received at Least 1 Dose of Study Drug | 12 mg/kg Ramucirumab (Part B) | 6 | |
| Overall Study | COMPLETED | 8 mg/kg Ramucirumab (Part A) | 6 | |
| Overall Study | COMPLETED | 12 mg/kg Ramucirumab (Part A) | 10 | |
| Overall Study | COMPLETED | 12 mg/kg Ramucirumab (Part B) | 6 | |
| Overall Study | NOT COMPLETED | 8 mg/kg Ramucirumab (Part A) | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events492
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 8 mg/kg Ramucirumab (Part A) | 2 | 8 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | 12 mg/kg Ramucirumab (Part A) | 9 | 15 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | 12 mg/kg Ramucirumab (Part B) | 2 | 6 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | 8 mg/kg Ramucirumab (Part A) | 0 | 8 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | 12 mg/kg Ramucirumab (Part A) | 1 | 15 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | 12 mg/kg Ramucirumab (Part B) | 0 | 6 | 0 |
| other | Sinus bradycardia | Cardiac disorders | 8 mg/kg Ramucirumab (Part A) | 1 | 8 | 1 |
| other | Sinus bradycardia | Cardiac disorders | 12 mg/kg Ramucirumab (Part A) | 1 | 15 | 1 |
| other | Sinus bradycardia | Cardiac disorders | 12 mg/kg Ramucirumab (Part B) | 0 | 6 | 0 |
| other | Sinus tachycardia | Cardiac disorders | 8 mg/kg Ramucirumab (Part A) | 2 | 8 | 2 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 8 mg/kg Ramucirumab (Part A) | 0 | 8 |
| Total, all-cause mortality | 12 mg/kg Ramucirumab (Part A) | 0 | 15 |
| Total, all-cause mortality | 12 mg/kg Ramucirumab (Part B) | 0 | 6 |
| Total, other adverse events | 8 mg/kg Ramucirumab (Part A) | 8 | 8 |
| Total, other adverse events | 12 mg/kg Ramucirumab (Part A) | 15 | 15 |
| Total, other adverse events | 12 mg/kg Ramucirumab (Part B) | 6 | 6 |
| Total, serious adverse events | 8 mg/kg Ramucirumab (Part A) | 3 | 8 |
| Total, serious adverse events | 12 mg/kg Ramucirumab (Part A) | 7 | 15 |
| Total, serious adverse events | 12 mg/kg Ramucirumab (Part B) | 2 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 8 mg/kg Ramucirumab (Part A) vs 12 mg/kg Ramucirumab (Part A): Part A: Number of Participants With Dose Limiting Toxicities (DLTs): Maximum Tolerated Dose of Ramucirumab |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02564198
GET https://conductscience.org/api/trials/v1/NCT02564198/events?page=2