CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Olaratumabbiological
Likely dose
Olaratumab 10 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01199822
NCT01199822Phase 1Completed
CompareCT.gov

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

Eli Lilly and Company·interventional·Posted Sep 13, 2010·Updated Apr 14, 2017

In Brief

A Phase 1 clinical trial evaluating Olaratumab for Malignancy and Metastasis. Completed, enrolled 16 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignancy, Metastasis
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2010
Enrollment StartSep 1, 2010
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.8 years ago

Interventions

Olaratumabbiological

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