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

Status: Recruiting
Phase: Phase 1
DFCI Protocol ID: 16-196

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.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Steven Dubois MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

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 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.

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