Neoplasms

All Conditions

Rare Diseases

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Olaratumab

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met

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15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 75 mg/m2 of doxorubicin administered IV on Day 1 every 21 day-cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.

20 mg/kg loading dose of olaratumab administered IV on Day 1 and Day 8 in Cycle 1, followed by 15 mg/kg IV on Day 1 and Day 8 in subsequent cycles, and 75 mg/m2 of doxorubicin administered IV on Day 1 of every 21 day-cycle up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.

15 mg/kg olaratumab administered IV on Day 1 and Day 8 of every 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT-5 hours, EST)

This study consists of 2 parts (Part A and Part B). The main purpose of Part A is to evaluate safety and side effects of olaratumab in combination with doxorubicin in Japanese participants with a group of rare cancers (advanced solid tumors, especially advanced soft tissue sarcoma \[STS\].) The main purpose of Part B is to evaluate how much olaratumab gets into the blood stream of Japanese participants with advanced solid tumors and how long it takes the body to get rid of it.

A Study of Olaratumab in Japanese Participants With Advanced Cancer

A Phase 1 Study of Olaratumab in Japanese Patients With Advanced Soft Tissue Sarcoma or Advanced Solid Tumors

Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 21) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

Maximum observed serum concentration (Cmax) of olaratumab is reported.

AUC(0-t) hours (h), area under the serum concentration versus time curve from time zero to t hours at AUC(0-168h) for Cycle 1 Day 1 and Cycle 3 Day 1, AUC(0-336h) for Cycle 1 Day 8 and Cycle 3 Day 8 of Olaratumab is reported.

Maximum observed plasma concentration (Cmax) of doxorubicin is reported.

Area under the concentration verses time curve from zero to infinity (AUC\[0-∞\]) of doxorubicin is reported.

Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1. Complete Response (CR) is disappearance of all target lesions; Partial Response (PR) is greater than or equal to (≥) 30% decrease in sum of longest diameter of target lesions.

Eli Lilly and Company

All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A and Part B.

15 mg/kg of olaratumab administered IV on Day 1 and Day 8, and 25 mg/m2 of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met.

Part A Cohort 1: Olaratumab+Doxorubicin

Part A Cohort 2: Olaratumab+Doxorubicin

Part A Cohort 3 Olaratumab + Doxorubicin

Part B: Olaratumab

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

Chief Medical Officer

All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) in Part A.

Part A: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

All enrolled patients who completed Cycle 1 (initial 21-day treatment period), or who discontinued due to DLT during Cycle 1 in Part A.

Part A: Number of Participants With Dose Limiting Toxicities (DLTs)

Cycle 1 Day 1

Cycle 1 Day 8

Cycle 3 Day 1

Cycle 3 Day 8

All enrolled participants who received any amount of study drug (olaratumab) and had evaluable pharmacokinetics (PK) data in Part B.

Part B: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab

Cycle 1 Day 1: AUC(0-168h)

Cycle 1 Day 8: AUC(0-336h)

Cycle 3 Day 1: AUC(0-168h)

Cycle 3 Day 8: AUC(0-336h)

All enrolled participants who received any amount of study drug (olaratumab) and had evaluable PK data in Part B.

Part B: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab

All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A.

Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Olaratumab

Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Olaratumab

Cycle 1 Day 2

Cycle 1 Day 3

Cycle 3 Day 2

Cycle 3 Day 3

Part A: Pharmacokinetics: Maximum Observed Concentration (Cmax) of Doxorubicin

All enrolled participants who received any amount of study drugs (either olaratumab or doxorubicin) and had evaluable PK data in Part A. AUC data is not available for Part A cohort 1 as PK was evaluated immediately post infusion of doxorubicin in Part A cohort 1.

Part A: Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of Doxorubicin

Change From Baseline in Percentage of Participants With a Tumor Response

15 milligram per kilogram (mg/kg) of olaratumab administered intravenously (IV) on Day 1 and Day 8, and 25 milligram per square meter (mg/m2) of doxorubicin administered IV on Day 1, Day 2, and Day 3 every 21-day cycle for up to 6 cycles or until the cumulative dose of doxorubicin reached 500 mg/m2, whichever came later, followed by 15 mg/kg of olaratumab IV monotherapy on Day 1 and Day 8 in subsequent cycles. Participants may continue to receive treatment until discontinuation criteria are met

Spots Global Cancer Trial Database for A Study of Olaratumab in Japanese Participants With Advanced Cancer

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