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

This study is currently recruiting participants.
Verified October 2017 by Eli Lilly and Company
Sponsor:
ClinicalTrials.gov Identifier:
NCT02677116
First Posted: February 9, 2016
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
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 two parts. In each part, a specific dose of olaratumab will be given for 21 days, followed by one of three standard chemotherapy regimens. Participants will only enroll in one part.

Condition Intervention Phase
Neoplasm Metastasis Drug: Olaratumab Drug: Doxorubicin Drug: Vincristine Drug: Irinotecan Drug: Ifosfamide Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with Olaratumab Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 in each arm (21 day cycle) ]

Secondary Outcome Measures:
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab [ Time Frame: Cycle 1 through Cycle 2 in each arm (21 day cycles; up to 42 days total) ]
  • Pharmacokinetics (PK): Trough Serum Concentration (Cmin) of Olaratumab [ Time Frame: Cycle 1 through Cycle 5 in each arm (21 day cycles; up to 105 days total) ]
  • Proportion of Participants With a Complete or Partial Response (Objective Response Rate [ORR]) [ Time Frame: Baseline to objective progression or start of new anti-cancer therapy (estimated up to 6 months) ]
  • Progression Free Survival [ Time Frame: Baseline to objective progression or death from any cause (estimated up to 6 months) ]

Estimated Enrollment: 70
Study Start Date: August 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olaratumab Alone (Part A)
Olaratumab administered intravenously (IV) on Days 1 and 8 for one cycle (21 days).
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Experimental: Olaratumab + Doxorubicin (Part A)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Doxorubicin
Doxorubicin administered IV.
Experimental: Olaratumab + Vincristine + Irinotecan (Part A)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Vincristine
Vincristine administered IV.
Drug: Irinotecan
Irinotecan administered IV.
Experimental: Olaratumab + Ifosfamide (Part A)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Ifosfamide
Ifosfamide administered IV.
Experimental: Olaratumab Alone (Part B)
Olaratumab administered intravenously (IV) on Days 1 and 8 for one cycle (21 days).
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Experimental: Olaratumab + Doxorubicin (Part B)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab administered IV on Days 1 and 8 and doxorubicin administered IV on Days 1 and 2. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Doxorubicin
Doxorubicin administered IV.
Experimental: Olaratumab + Vincristine + Irinotecan (Part B)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab and vincristine administered IV on Days 1 and 8. Irinotecan administered IV on Days 1 through 5. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Vincristine
Vincristine administered IV.
Drug: Irinotecan
Irinotecan administered IV.
Experimental: Olaratumab + Ifosfamide (Part B)
One cycle of olaratumab alone (administered IV on Days 1 and 8). For all subsequent cycles, olaratumab administered IV on Days 1 and 8 of each cycle. Ifosfamide administered IV on Days 1 though 5. All cycles are 21 days. Treatment will cease when discontinuation criterion is met.
Drug: Olaratumab
Olaratumab administered IV.
Other Name: LY3012207
Drug: Ifosfamide
Ifosfamide administered IV.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 study drug, as appropriate.
  • 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 study drug 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677116


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 24 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02677116     History of Changes
Other Study ID Numbers: 15841
I5B-MC-JGDN ( Other Identifier: Eli Lilly and Company )
First Submitted: January 29, 2016
First Posted: February 9, 2016
Last Update Posted: October 19, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Doxorubicin
Liposomal doxorubicin
Irinotecan
Isophosphamide mustard
Olaratumab
Camptothecin
Vincristine
Ifosfamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Alkylating
Alkylating Agents