臨床研究等提出・公開システム

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

I5B-MC-JGDN

No

Eli Lilly Japan K.K.

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Eli Lilly Japan K.K.

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+81-120-023-812

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completed

June. 18, 2018

Interventional

Non-Randomized

treatment purpose

1

- 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

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.

Both

Neoplasm Metastasis

investigational material(s)
Generic name etc : Olaratumab
INN of investigational material : Olaratumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Olaratumab administered IV on Days 1 and 8
Generic name etc : Doxorubicin
INN of investigational material : Doxorubicin
Therapeutic category code : 423 Antitumor antibiotics and preparations
Dosage and Administration for Investigational material : Doxorubicin administered IV on Days 1 and 2
Generic name etc : Vincristine
INN of investigational material : Vincristine
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Vincristine administered IV on Days 1 and 8
Generic name etc : Irinotecan
INN of investigational material : Irinotecan
Therapeutic category code : 424 Antineoplastic preparations extracted from plants
Dosage and Administration for Investigational material : Irinotecan administered IV on Days 1 through 5
Generic name etc : Ifosfamide
INN of investigational material : Ifosfamide
Therapeutic category code : 421 Alkylating agents
Dosage and Administration for Investigational material : Ifosfamide administered IV on Days 1 through 5

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

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)

pharmacokinetics
Pharmacokinetics (PK)

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May. 09, 2018