Neoplasm Metastasis
Conditions
Interventions
investigational material(s)
Generic name etc : Olaratumab
INN of investigational material : Olaratumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion 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 (greater-than or equal to 16 years of age) performance score of at least 50. - The participant has adequate hematologic, organ, and coagulation function less-than or equal to 2 weeks (14 days) prior to first dose of study drug: Absolute neutrophil count (ANC) greater-than or equal to 750/mm3 Platelets greater-than or equal to 75,000/mm3 Hemoglobin greater-than or equal to 8 grams per deciliter (g/dL) Total bilirubin (sum of conjugated + unconjugated) less-than or equal to 1.5 x upper limit of normal (ULN) for age Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less-than or equal to 3.0 x ULN Serum creatinine is based on age/gender Adequate coagulation function as defined by International Normalized Ratio less-than or equal to 1.5 or prothrombin time less-than or equal to 1.5 x ULN, and partial thromboplastin time less-than or equal to 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Pharmacokinetics (PK) | — |
Countries
Japan, North America
Outcome results
None listed