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Olaratumab

Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks

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Participants in this single-center, open-label, dose-escalation, Phase 1 study will initially receive intravenous (IV) olaratumab once every 2 weeks or on Days 1 and 8 every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing an overall response of complete response (CR), partial response (PR), or stable disease (SD) will continue to receive olaratumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met.

Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors

A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-3G3 Administered in a 2-week, or 3-week Schedule to Japanese Patients With Advanced Solid Tumors

Data presented are the number of participants who experienced AEs of any grade and AEs of Grade ≥3 as determined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.02. A summary of serious adverse events (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

A DLT is defined as 1 of the following events, if considered by the investigator to be definitely, probably, or possibly related to olaratumab: NCI-CTCAE v4.02 Grade 4 neutropenia lasting \>7 days; NCI-CTCAE v4.02 Grade ≥3 thrombocytopenia with signs of bleeding or requiring platelet transfusions; NCI-CTCAE v4.02 Grade ≥3 neutropenia associated with fever; NCI-CTCAE v4.02 Grade 3 or 4 nonhematologic toxicity, excluding electrolyte abnormality; NCI-CTCAE v4.02 Grade ≥3 skin toxicity despite best preemptive and supportive care; and/or NCI-CTCAE v4.02 Grade ≥3 diarrhea, nausea, or vomiting despite best preemptive and supportive care.

t1/2 is the time it takes for the drug concentration in serum to decrease to half the value observed at the beginning of the time period.

CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.

Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.

Data presented are the number of participants who experienced a treatment related AE of any grade.

Eli Lilly and Company

10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.

10 mg/kg Olaratumab

20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.

20 mg/kg Olaratumab

15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.

15 mg/kg Olaratumab

Total

20 - <65 Years

≥65 Years

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Japan

Region of Enrollment

All enrolled participants who received at least 1 dose of study drug.

Chief Medical Officer

AE of Any Grade

AE of Grade ≥3

Number of Participants With Adverse Events (AEs)

Number of Participants With SAEs

10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.

20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycle 1.

15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.

Number of Participants With a Dose- Limiting Toxicity (DLT) in Cycle 1

10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.

20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.

15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.

All participants who received study drug and had pharmacokinetic (PK) data available to calculate Cmax. Due to the limited data, Cmax is not representative of the study population.

Maximum Concentration (Cmax) of Olaratumab Following Multiple Doses

All participants who received study drug and had PK data available to calculate AUCτ. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to the limited data, AUCτ is not representative of the study population.

Area Under the Concentration of Olaratumab Versus Time Curve During One Dosing Interval (AUCτ) Following Multiple Doses

All participants who received study drug and had PK data available to calculate t1/2. Due to limited data and the relatively short duration of sample collection, t1/2 is not representative of the study population.

Terminal Elimination Half-Life (t1/2) of Olaratumab

All participants who received study drug and had PK data available to calculate CLss. Zero participants were analyzed for groups of 10 mg/kg IMC-3G3 and 15 mg/kg IMC-3G3 because of insufficient amount of samples collected. Due to limited data, CLss is not representative of the study population.

Clearance of Olaratumab at Steady State (CLss)

Zero participants were analyzed because of insufficient amount of samples collected.

Volume of Distribution at Steady State (Vss)

10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.

All participants who received at least one dose of study drug and had evaluable baseline and evaluable post-baseline antibody data.

Number of Participants With Serum Anti-Olaratumab Antibody Assessment (Immunogenicity)

Any treatment related AE

Anaemia

Leukopenia

Diarrhoea

Fatigue

Aspartate aminotransferase increased

Fibrin D dimer increased

Hyperglycaemia

Tumour haemorrhage

Proteinuria

Cough

Dermatitis

Rash

Hypertension

Number of Participants With Treatment Related AEs

10 milligrams/kilogram (mg/kg) olaratumab intravenously (IV) administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of progressive disease (PD), or until other withdrawal criteria were met.

Spots Global Cancer Trial Database for Study of the Safety and Pharmacokinetics of Olaratumab (IMC-3G3) in Japanese Participants With Solid Tumors

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