Neoplasm MetastasisPhase 1NCT02677116
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
A Phase 1 study testing Olaratumab, Doxorubicin and Vincristine in people with Neoplasm Metastasis, run by Eli Lilly and Company at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Olaratumab, Doxorubicin and Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 29 Aug 2016to 3 Apr 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
The Children's Hospital for Cancer and Blood Disorders
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Levine Children's Hospital
Charlotte, North Carolina, 28203
Mary Crowley Cancer Research Center
Dallas, Texas, 75230
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Texas Childrens Hospital
Houston, Texas, 77030
Riley Hosptial for Children
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
St Jude Childrens Research Hospital
Memphis, Tennessee, 38105
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-6307
Cohen Children's Medical Center
New Hyde Park, New York, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Primary Childrens Medical Center
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94158
Seattle Children's Hospital Research Foundation
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
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
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.
- Conditions
- Neoplasm Metastasis
- Being tested
- Olaratumab, Doxorubicin, Vincristine, Irinotecan, Ifosfamide
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaratumabDrug
Also called LY3012207
Olaratumab administered IV.
DoxorubicinDrug
Doxorubicin administered IV.
VincristineDrug
Vincristine administered IV.
IrinotecanDrug
Irinotecan administered IV.
IfosfamideDrug
Ifosfamide administered IV.
| Study group | Role | What they receive |
|---|---|---|
| Olaratumab + Doxorubicin (Part A) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Doxorubicin |
| Olaratumab + Vincristine + Irinotecan (Part A) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Vincristine; Drug: Irinotecan |
| Olaratumab + Ifosfamide (Part A) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Ifosfamide |
| Olaratumab + Doxorubicin (Part B) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Doxorubicin |
| Olaratumab + Vincristine + Irinotecan (Part B) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Vincristine; Drug: Irinotecan |
| Olaratumab + Ifosfamide (Part B) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Doxorubicin; Drug: Ifosfamide |
| Olaratumab + Doxorubicin (Part C) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Doxorubicin |
| Olaratumab + Vincristine + Irinotecan (Part C) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Vincristine; Drug: Irinotecan |
| Olaratumab + Ifosfamide (Part C) | Experimental | 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. Receives: Drug: Olaratumab; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Parts A and B: Cycle 1 through Cycle 2 in each arm (21-day cycle); Part C: Cycle 1 only (21-day cycle)
Secondary outcomes (9)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Measured: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Maximum Concentration (Cmax) of Olaratumab Part B
PK: Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Measured: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Pharmacokinetics (PK): Maximum serum concentration (Cmax) data of Olaratumab was reported from available sample data.
Measured: Cycle 1, Days 1 and 8; Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
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.
Measured: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
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.
Measured: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
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.
Measured: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
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.
Measured: Baseline to objective progression or start of new anti-cancer therapy (Up to 7 months)
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.
Measured: Baseline to radiological disease progression or death from any cause (Up to 2 Years)
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.
Measured: From Baseline to Study Completion (Up to 33 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start29 Aug 2016
- Primary completion10 Oct 2018
- Study completion3 Apr 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 Neoplasm MetastasisStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677116
- Sponsor's protocol ID
- 15841
- Other IDs
- I5B-MC-JGDN
- Status last verified
- 1 Jun 2019
- First submitted
- 29 Jan 2016
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02677116
- Acronym / sponsor ID
- 15841
- Conditions
- Neoplasm Metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 20 May 2020
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Olaratumab + Doxorubicin (Part A) | Experimental | Drug: Olaratumab, Drug: DoxorubicinCycle 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. |
| Olaratumab + Vincristine + Irinotecan (Part A) | Experimental | Drug: Olaratumab, Drug: Vincristine, Drug: IrinotecanCycle 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. |
| Olaratumab + Ifosfamide (Part A) | Experimental | Drug: Olaratumab, Drug: IfosfamideCycle 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. |
| Olaratumab + Doxorubicin (Part B) | Experimental | Drug: Olaratumab, Drug: DoxorubicinCycle 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. |
| Olaratumab + Vincristine + Irinotecan (Part B) | Experimental | Drug: Olaratumab, Drug: Vincristine, Drug: IrinotecanCycle 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. |
| Olaratumab + Ifosfamide (Part B) | Experimental | Drug: Olaratumab, Drug: Doxorubicin, Drug: IfosfamideCycle 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. |
| Olaratumab + Doxorubicin (Part C) | Experimental | Drug: Olaratumab, Drug: DoxorubicinCycle 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. |
| Olaratumab + Vincristine + Irinotecan (Part C) | Experimental | Drug: Olaratumab, Drug: Vincristine, Drug: IrinotecanCycle 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. |
| Olaratumab + Ifosfamide (Part C) | Experimental | Drug: Olaratumab, Drug: IfosfamideCycle 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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).
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 |
|---|---|---|
| OlaratumabAlso: LY3012207Olaratumab administered IV. | Drug | Olaratumab + Doxorubicin (Part A), Olaratumab + Doxorubicin (Part B), Olaratumab + Doxorubicin (Part C), Olaratumab + Ifosfamide (Part A), Olaratumab + Ifosfamide (Part B), Olaratumab + Ifosfamide (Part C), Olaratumab + Vincristine + Irinotecan (Part A), Olaratumab + Vincristine + Irinotecan (Part B), Olaratumab + Vincristine + Irinotecan (Part C) |
| DoxorubicinDoxorubicin administered IV. | Drug | Olaratumab + Doxorubicin (Part A), Olaratumab + Doxorubicin (Part B), Olaratumab + Doxorubicin (Part C), Olaratumab + Ifosfamide (Part B) |
| VincristineVincristine administered IV. | Drug | Olaratumab + Vincristine + Irinotecan (Part A), Olaratumab + Vincristine + Irinotecan (Part B), Olaratumab + Vincristine + Irinotecan (Part C) |
| IrinotecanIrinotecan administered IV. | Drug | Olaratumab + Vincristine + Irinotecan (Part A), Olaratumab + Vincristine + Irinotecan (Part B), Olaratumab + Vincristine + Irinotecan (Part C) |
| IfosfamideIfosfamide administered IV. | Drug | Olaratumab + Ifosfamide (Part A), Olaratumab + Ifosfamide (Part B), Olaratumab + Ifosfamide (Part C) |
Primary outcome
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs)
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)
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.
9 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Part A
Time frame: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Maximum Concentration (Cmax) of Olaratumab Part B
Time frame: Cycle 1, Day 8 and Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Maximum Concentration (Cmax) of Olaratumab Part C
Time frame: Cycle 1, Days 1 and 8; Cycle 2, Days 1 and 8: 1.25 hour (h), 2.5 h, 3.5h Postdose
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part A
Time frame: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part B
Time frame: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
PK: Trough Serum Minimum Concentration (Cmin) of Olaratumab Part C
Time frame: Cycles 1, 2, 3-25; Day 8: 336 Hours Postdose
Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Time frame: Baseline to objective progression or start of new anti-cancer therapy (Up to 7 months)
Progression Free Survival (PFS)
Time frame: Baseline to radiological disease progression or death from any cause (Up to 2 Years)
Percentage of Participants With Treatment Emergent (TE) Positive Anti-Olaratumab Antibodies
Time frame: From Baseline to Study Completion (Up to 33 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaratumab, Doxorubicin and Vincristine in people with Neoplasm Metastasis, run by Eli Lilly and Company at 21 sites in 2 countries.
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 20 inclusion and 6 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 20 May 2020. 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, Japan. 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 20 May 2020). 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?
Number of Participants With Olaratumab Dose Limiting Toxicities (DLTs) (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.