CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
IMC-A12 (Cixutumumab)drug
Likely dose
IMC-A12 (Cixutumumab) 10 mg/kgfrom 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/NCT00520481
NCT00520481Phase 2Completed
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Phase 2 Single Arm, Open-Label Study of IMC-A12 in Asymptomatic, Chemotherapy-Naïve Patients With Metastatic Androgen-Independent Prostate Cancer

Eli Lilly and Company·interventional·Posted Aug 24, 2007·Updated Jul 19, 2018

In Brief

A Phase 2 clinical trial evaluating IMC-A12 (Cixutumumab) for Adenocarcinoma of the Prostate. Completed, enrolled 41 participants across 3 sites.

Detailed Summary

This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2). Treatment will continue until there is evidence of disease progression, intolerable toxicity, or other withdrawal criteria are met. Non-surgically castrated participants must continue the use of luteinizing hormone-releasing hormone (LHRH) agonists during protocol treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 24, 2007
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.9 years ago

Interventions

IMC-A12 (Cixutumumab)drug

10 mg/kg i.v. infusion over 1 hour every 2 weeks or 20 mg/kg i.v. infusion over 1 hour every 3 weeks.