Pediatric Solid TumorPhase 1NCT02564198

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

A Phase 1 study testing Ramucirumab in people with Pediatric Solid Tumor and Refractory Tumor, run by Eli Lilly and Company at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 12 months to 21 years
Conditions the study is for: Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor
What is being tested?: Ramucirumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 21 sitesUnited States
Study dates: 11 Dec 2015to 16 Jul 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

United States21 sites

University of Michigan Health Systems
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30322
Mark O Harfield-Warren Grant Magnuson Clinical Center
Bethesda, Maryland, 20892
Childrens Hospital of Alabama
Birmingham, Alabama, 35233
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Texas Childrens Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Hospital
Minneapolis, Minnesota, 55455
Children's Oncology Group
Monrovia, California, 91016
Columbia University Medical Center
New York, New York, 10032
Childrens Hospital of Orange County
Orange, California, 92868
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Oregon Health and Science University
Portland, Oregon, 97239
University of California, San Francisco
San Francisco, California, 94158
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105
Washington University Medical School
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

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

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.

Conditions: Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies
Being tested: Ramucirumab
Keywords: relapsed pediatric solid tumors, unspecified childhood solid tumor, brain and central nervous system tumors
Medical subject headings: Neoplasms, Recurrence, Central Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RamucirumabDrug
Also called LY3009806, IMC-1121B, Cyramza
Administered IV

Study groups in NCT02564198
Study group	Role	What they receive
Ramucirumab	Experimental	(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. Receives: Drug: Ramucirumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
2. Grade ≥3 prolongation of QT interval corrected using the Fridericia formula on 2 separate electrocardiogram readings approximately 5 min apart.
Measured: Baseline to Study Completion (Up to 42 Months)
Population Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.
Measured: Predose, Cycle 1 Day 1 (end of infusion (EOI), 1 hour after EOI) and Cycle 1 Day 43 (1 hour after EOI)
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.
Measured: Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months)

Secondary outcomes (4)

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.
Measured: Baseline to Date of Objective Disease Progression (Up to 42 Months)
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.
Measured: Baseline to Date of Objective Disease Progression (Up to 42 Months)
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.
Measured: 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)
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.
Measured: Baseline to Date of Death from Any Cause (Up to 42 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Dec 201516 Jul 2019

First posted30 Sep 2015 (estimated)
Study start11 Dec 2015
Primary completion16 Jul 2019
Study completion16 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pediatric Solid TumorStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02564198
Sponsor's protocol ID: 15542
Other IDs: I4T-MC-JVDA, ADVL1416
Status last verified: Jul 2021
First submitted: 25 Sep 2015
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediatric Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02564198
Acronym / sponsor ID: 15542
Conditions: Pediatric Solid Tumor, Refractory Tumor, Recurrent Tumor, CNS Malignancies
Keywords: relapsed pediatric solid tumors, unspecified childhood solid tumor, brain and central nervous system tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Children's Oncology Group
Study start: 11 Dec 2015 (actual)
Primary completion: 16 Jul 2019 (actual)
Study completion: 16 Jul 2019 (actual)
First posted: 30 Sep 2015 (estimated)
Results: Posted 17 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ramucirumab	Experimental	Drug: Ramucirumab(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.

Who may qualify

Ages: 12 months to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RamucirumabAlso: LY3009806, IMC-1121B, CyramzaAdministered IV	Drug	Ramucirumab

Primary outcome

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)
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.
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)
Population Pharmacokinetics (PK): Minimum observed plasma concentration of Ramucirumab.
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: 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.

4 secondary outcomes

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)
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)
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)
Overall Survival
Time frame: Baseline to Date of Death from Any Cause (Up to 42 Months)

Results and safety

Results posted to the registry on 17 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
8 mg/kg Ramucirumab (Part A)	8	6
12 mg/kg Ramucirumab (Part A)	15	10
12 mg/kg Ramucirumab (Part B)	6	6

Primary outcome: 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). Number. Unit: Participants

Measure	8 mg/kg Ramucirumab (Part A) n = 8	12 mg/kg Ramucirumab (Part A) n = 15
Value	1	1

Population analysed: All randomized participants from Part A, who received at least one dose of study drug.

Primary outcome: 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). Geometric mean (Geometric Coefficient of Variation). Unit: microgram per milliliter (µg/mL)

Measure	8 mg/kg Ramucirumab n = 8	12 mg/kg Ramucirumab n = 19
Cycle 1 Day 1	30.0 (32)	48.3 (41)
Cycle 1 Day 43	53.6 (31)	80.2 (44)

Population analysed: 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.

Primary outcome: Number of Participants With Anti-Ramucirumab Antibodies

Time frame: Predose Cycle 1 Day 1 through Follow-Up (Up to 42 Months). Number. Unit: participants

Measure	8 mg/kg Ramucirumab (Part A) n = 8	12 mg/kg Ramucirumab (Part A) n = 15	12 mg/kg Ramucirumab (Part B) n = 6
Value	0	0	0

Population analysed: All randomized participants who received at least one dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline, up to 4 years 8 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
8 mg/kg Ramucirumab (Part A)	3 of 8 (37.5%)	8 of 8 (100%)	0 of 8
12 mg/kg Ramucirumab (Part A)	7 of 15 (46.7%)	15 of 15 (100%)	0 of 15
12 mg/kg Ramucirumab (Part B)	2 of 6 (33.3%)	6 of 6 (100%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Click here for more information about this study: A Study of Ramucirumab (LY3009806) in Children With Refractory Solid TumorsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab in people with Pediatric Solid Tumor and Refractory Tumor, run by Eli Lilly and Company at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02564198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.