A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT02677116
Phase
PHASE1
Status
Completed

Conditions

  • Neoplasm Metastasis

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaratumab — DRUG
    Olaratumab administered IV.
  • Doxorubicin — DRUG
    Doxorubicin administered IV.
  • Vincristine — DRUG
    Vincristine administered IV.
  • Irinotecan — DRUG
    Irinotecan administered IV.
  • Ifosfamide — DRUG
    Ifosfamide administered IV.

Study Details

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.

Key Dates

Start date
Aug 29, 2016
Status verified
Jun 2019
Primary completion
Oct 10, 2018
Completion
Apr 3, 2019

Study Design

Enrollment
68 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaratumab + Doxorubicin (Part A)
    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.
  • Experimental: Olaratumab + Vincristine + Irinotecan (Part A)
    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.
  • Experimental: Olaratumab + Ifosfamide (Part A)
    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.
  • Experimental: Olaratumab + Doxorubicin (Part B)
    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.
  • Experimental: Olaratumab + Vincristine + Irinotecan (Part B)
    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.
  • Experimental: Olaratumab + Ifosfamide (Part B)
    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.
  • Experimental: Olaratumab + Doxorubicin (Part C)
    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.
  • Experimental: Olaratumab + Vincristine + Irinotecan (Part C)
    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.
  • Experimental: Olaratumab + Ifosfamide (Part C)
    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.

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) ]

Locations (20)

FacilityCityStateZIPSite coordinators
Phoenix Childrens HospitalPhoenixArizona85016-
Childrens Hospital of Los AngelesLos AngelesCalifornia90027-
University of California, San FranciscoSan FranciscoCalifornia94158-
The Children's Hospital for Cancer and Blood DisordersAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-2970-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Riley Hosptial for ChildrenIndianapolisIndiana46202-
Dana Farber Cancer InstituteBostonMassachusetts02115-
University of Minnesota Medical SchoolMinneapolisMinnesota55455-
Children's Mercy HospitalKansas CityMissouri64108-
Cohen Children's Medical CenterNew Hyde ParkNew York11040-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Levine Children's HospitalCharlotteNorth Carolina28203-
St Jude Childrens Research HospitalMemphisTennessee38105-
Vanderbilt University Medical CenterNashvilleTennessee37232-6307-
Mary Crowley Cancer Research CenterDallasTexas75230-
University of Texas Southwestern Medical Center at DallasDallasTexas75235-
Texas Childrens HospitalHoustonTexas77030-
Primary Childrens Medical CenterSalt Lake CityUtah84132-
Seattle Children's Hospital Research FoundationSeattleWashington98105-

Find similar trials in Phoenix, AZ

By research site
Phoenix Childrens Hospital· Phoenix, AZChildrens Hospital of Los Angeles· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAThe Children's Hospital for Cancer and Blood Disorders· Aurora, COChildren's National Medical Center· Washington D.C., DCSylvester Comprehensive Cancer Center· Miami, FL

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