CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
Cixutumumabbiological
Likely dose
Not stated in 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/NCT01007032
NCT01007032Phase 1Completed

A Phase 1 Study Evaluating the Safety and Pharmacokinetic Profiles of IMC-A12 Administered Every 2 Weeks or Every 3 Weeks to Japanese Patients With Advanced Solid Tumors

Eli Lilly and Company·interventional·Posted Nov 3, 2009·Updated Feb 27, 2019

In Brief

A Phase 1 clinical trial evaluating Cixutumumab for Tumors. Completed, enrolled 21 participants across 1 site.

Detailed Summary

In this study, participants will initially receive intravenous (IV) cixutumumab (IMC-A12) every 2 weeks or every 3 weeks for 6 weeks (one cycle). After the first cycle, participants experiencing a best overall response of complete response, partial response, or stable disease will continue to receive cixutumumab at their cohort dose and schedule until there is evidence of progressive disease (PD), or until other withdrawal criteria are met. Participants will be enrolled at one study center, located in the National Cancer Center Hospital - East, Kashiwa, Japan. Approximately 20-30 participants are anticipated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTumors
CountriesJapan

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2009
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2012
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.7 years ago

Interventions

Cixutumumabbiological

Cixutumumab intravenously