Back to resultsA Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Olaratumab
Doxorubicin
Vincristine
Irinotecan
Ifosfamide
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis
Eligibility Criteria
Inclusion Criteria:
- The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
- The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
- The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
The participant has adequate hematologic, organ, and coagulation function ≤2 weeks (14 days) prior to first dose of study drug:
- Absolute neutrophil count (ANC) ≥750 cubic millimeters (mm³)
- Platelets ≥75,000/mm³
- Hemoglobin ≥8 grams per deciliter (g/dL)
- Total bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
- Serum creatinine is based on age/gender
- Adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5 x ULN, and partial thromboplastin time ≤1.5 x ULN
- Both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of olaratumab, or longer for other study drugs according to their label.
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
- Myelosuppressive chemotherapy
- Hematopoietic growth factors
- Biologic (anti-neoplastic agent)
- Antibody therapy
- Radiation
- Stem cell infusion without traumatic brain injury
- Corticosteroids
Exclusion Criteria:
- Have received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Participants that have had bone marrow or solid organ transplant are excluded.
- The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
- Female participants who are pregnant or breastfeeding are excluded.
- If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram (either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not both).
- Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
Sites / Locations
- Phoenix Childrens Hospital
- Childrens Hospital of Los Angeles
- University of California, San Francisco
- The Children's Hospital for Cancer and Blood Disorders
- Children's National Medical Center
- Sylvester Comprehensive Cancer Center
- Riley Hosptial for Children
- Dana Farber Cancer Institute
- University of Minnesota Medical School
- Children's Mercy Hospital
- Cohen Children's Medical Center
- Memorial Sloan Kettering Cancer Center
- Levine Children's Hospital
- St Jude Childrens Research Hospital
- Vanderbilt University Medical Center
- Mary Crowley Cancer Research Center
- University of Texas Southwestern Medical Center at Dallas
- Texas Childrens Hospital
- Primary Childrens Medical Center
- Seattle Children's Hospital Research Foundation
- National Cancer Center Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Olaratumab + Doxorubicin (Part A)
Olaratumab + Vincristine + Irinotecan (Part A)
Olaratumab + Ifosfamide (Part A)
Olaratumab + Doxorubicin (Part B)
Olaratumab + Vincristine + Irinotecan (Part B)
Olaratumab + Ifosfamide (Part B)
Olaratumab + Doxorubicin (Part C)
Olaratumab + Vincristine + Irinotecan (Part C)
Olaratumab + Ifosfamide (Part C)
Arm Description
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8. Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met. All cycles are 21 days.
Outcomes
Primary Outcome Measures
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of >14 days.
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
PK: Maximum Concentration (Cmax) of Olaratumab Part B
PK: Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Objective Response Rate (ORR) is the percentage of participants achieving a confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions.
Progression Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from baseline to the first date of radiological disease progression or death due to any cause. Progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.
Percentage of Participants With Treatment Emergent (TE) Positive Anti-Olaratumab Antibodies
Percentage of participants with a TE positive anti-olaratumab antibodies defined as a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02677116
Brief Title
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
Official Title
A Phase 1, Open-Label, Dose-Escalation Study of Olaratumab as a Single Agent and in Combination With Doxorubicin, Vincristine/Irinotecan, or High-Dose Ifosfamide in Pediatric Patients With Relapsed or Refractory Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 1, 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
April 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olaratumab + Doxorubicin (Part A)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Vincristine + Irinotecan (Part A)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Ifosfamide (Part A)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 15 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 15 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Doxorubicin (Part B)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Vincristine + Irinotecan (Part B)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Ifosfamide (Part B)
Arm Type
Experimental
Arm Description
Cycle 1: Olaratumab 20 mg/kg was administered IV Days 1 and 8.
Cycle 2 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Doxorubicin (Part C)
Arm Type
Experimental
Arm Description
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Vincristine + Irinotecan (Part C)
Arm Type
Experimental
Arm Description
Cycle 1 and beyond: Olaratumab 20 mg/kg and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Arm Title
Olaratumab + Ifosfamide (Part C)
Arm Type
Experimental
Arm Description
Cycle 1 and beyond: Olaratumab 20 mg/kg administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 through 5. Treatment will cease when discontinuation criterion is met.
All cycles are 21 days.
Intervention Type
Drug
Intervention Name(s)
Olaratumab
Other Intervention Name(s)
LY3012207
Intervention Description
Olaratumab administered IV.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin administered IV.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine administered IV.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan administered IV.
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Description
Ifosfamide administered IV.
Primary Outcome Measure Information:
Title
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
Description
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: CTCAE Grade 3 nonhematologic toxicity, grade 4 neutropenia that lasted longer than 2 weeks, grade ≥3 thrombocytopenia complicated by hemorrhage, and any hematologic toxicity that caused a cycle delay of >14 days.
Time Frame
Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Description
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Time Frame
Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
Title
PK: Maximum Concentration (Cmax) of Olaratumab Part B
Description
PK: Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Time Frame
Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
Title
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Description
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Time Frame
Cycle 1, Days 1 and 8; Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
Title
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
Description
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Time Frame
Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
Title
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
Description
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Time Frame
Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
Title
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
Description
PK: Trough serum concentration (Cmin) of Olaratumab was reported. A sample was collected every other cycle from cycles 1, 2, 3-25.
Time Frame
Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
Title
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description
Objective Response Rate (ORR) is the percentage of participants achieving a confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions.
Time Frame
Baseline to objective progression or start of new anti-cancer therapy (Up to 7 months)
Title
Progression Free Survival (PFS)
Description
Progression-free survival (PFS) is defined as the time from baseline to the first date of radiological disease progression or death due to any cause. Progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression. If participant started new treatment before PD, the participant was censored at the date of last tumor assessment prior to new therapy. If treatment was discontinued for reasons other than PD and no further assessment, censoring occurred at last tumor assessment.
Time Frame
Baseline to radiological disease progression or death from any cause (Up to 2 Years)
Title
Percentage of Participants With Treatment Emergent (TE) Positive Anti-Olaratumab Antibodies
Description
Percentage of participants with a TE positive anti-olaratumab antibodies defined as a participant with a 4-fold (2 dilutions) increase over a positive baseline antibody titer.
Time Frame
From Baseline to Study Completion (Up to 33 Months)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant must have histological or cytological evidence of a diagnosis of solid tumor, excluding lymphomas and melanoma, but including central nervous system (CNS) tumors, that is relapsed or refractory, not be amenable to curative treatment.
The participant has the presence of measurable and/or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST Version 1.1). Response Assessment in Neuro-Oncology (RANO) Criteria or Macdonald Criteria should be used for CNS tumors.
The participant has a Lansky (<16 years of age) or Karnofsky (≥16 years of age) performance score of at least 50.
The participant has adequate hematologic, organ, and coagulation function ≤2 weeks (14 days) prior to first dose of study drug:
Absolute neutrophil count (ANC) ≥750 cubic millimeters (mm³)
Platelets ≥75,000/mm³
Hemoglobin ≥8 grams per deciliter (g/dL)
Total bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN
Serum creatinine is based on age/gender
Adequate coagulation function as defined by International Normalized Ratio ≤1.5 or prothrombin time ≤1.5 x ULN, and partial thromboplastin time ≤1.5 x ULN
Both female and male participants of child-bearing potential must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of olaratumab, or longer for other study drugs according to their label.
Participants must have fully recovered from the acute toxic effects of all prior anticancer therapies or must adhere to post-treatment conditions as follows:
Myelosuppressive chemotherapy
Hematopoietic growth factors
Biologic (anti-neoplastic agent)
Antibody therapy
Radiation
Stem cell infusion without traumatic brain injury
Corticosteroids
Exclusion Criteria:
Have received treatment within 21 days of the initial dose of olaratumab with an investigational product or non-approved use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Participants that have had bone marrow or solid organ transplant are excluded.
The participant has an active fungal, bacterial, and/or known severe viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not required).
Female participants who are pregnant or breastfeeding are excluded.
If the participant is to be enrolled in the doxorubicin combination arm, a left ventricular dysfunction (LVEF < 50%) or shortening fraction of <27% by echocardiogram (either multigated acquisition [MUGA] or echocardiogram [ECHO] are required, not both).
Participants that have received prior anthracycline therapy if the participant is to be enrolled in the doxorubicin combination arm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Childrens Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
The Children's Hospital for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Riley Hosptial for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota Medical School
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
St Jude Childrens Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Mary Crowley Cancer Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Childrens Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Children's Hospital Research Foundation
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
National Cancer Center Hospital
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.lillytrialguide.com/en-US/studies/pediatric-neoplasm%20metastasis/JGDN#?postal=
Description
Click here for more information about this study: A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
Learn more about this trial
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
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