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

NCT ID: NCT02677116

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-29
• Study Completion Date: 2019-04-03

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.

Conditions

Neoplasm Metastasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Doxorubicin

Intervention Type: DRUG

Doxorubicin administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Vincristine

Intervention Type: DRUG

Vincristine administered IV.

Irinotecan

Intervention Type: DRUG

Irinotecan administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Ifosfamide

Intervention Type: DRUG

Ifosfamide administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Doxorubicin

Intervention Type: DRUG

Doxorubicin administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Vincristine

Intervention Type: DRUG

Vincristine administered IV.

Irinotecan

Intervention Type: DRUG

Irinotecan administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Doxorubicin

Intervention Type: DRUG

Doxorubicin administered IV.

Ifosfamide

Intervention Type: DRUG

Ifosfamide administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Doxorubicin

Intervention Type: DRUG

Doxorubicin administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Vincristine

Intervention Type: DRUG

Vincristine administered IV.

Irinotecan

Intervention Type: DRUG

Irinotecan administered IV.

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.

Group Type: EXPERIMENTAL

Olaratumab

Intervention Type: DRUG

Olaratumab administered IV.

Ifosfamide

Intervention Type: DRUG

Ifosfamide administered IV.

Interventions

Olaratumab

Olaratumab administered IV.

Intervention Type: DRUG

Doxorubicin

Doxorubicin administered IV.

Intervention Type: DRUG

Vincristine

Vincristine administered IV.

Intervention Type: DRUG

Irinotecan

Irinotecan administered IV.

Intervention Type: DRUG

Ifosfamide

Ifosfamide administered IV.

Intervention Type: DRUG

Other Intervention Names

LY3012207

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal 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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Childrens Hospital of Los Angeles

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

The Children's Hospital for Cancer and Blood Disorders

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Riley Hosptial for Children

Indianapolis, Indiana, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota Medical School

Minneapolis, Minnesota, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Cohen Children's Medical Center

New Hyde Park, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Levine Children's Hospital

Charlotte, North Carolina, United States

St Jude Childrens Research Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Mary Crowley Cancer Research Center

Dallas, Texas, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Texas Childrens Hospital

Houston, Texas, United States

Primary Childrens Medical Center

Salt Lake City, Utah, United States

Seattle Children's Hospital Research Foundation

Seattle, Washington, United States

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

Countries

United States; Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.lillytrialguide.com/en-US/studies/pediatric-neoplasm%20metastasis/JGDN#?postal=

Click here for more information about this study: A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer

Other Identifiers

I5B-MC-JGDN

Identifier Type: OTHER

Identifier Source: secondary_id

15841

Identifier Type: -

Identifier Source: org_study_id