CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Olaratumab +2 morebiological
Likely dose
Olaratumab 15 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/NCT01204710
NCT01204710Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody IMC-3G3 Plus Mitoxantrone Plus Prednisone or Mitoxantrone Plus Prednisone in Metastatic Castration-Refractory Prostate Cancer Following Disease Progression or Intolerance on Docetaxel-based Chemotherapy

Eli Lilly and Company·interventional·Posted Sep 17, 2010·Updated Sep 20, 2019

In Brief

A Phase 2 clinical trial evaluating Olaratumab, Mitoxantrone, and 1 other intervention for Prostate Cancer. Completed, enrolled 123 participants across 40 sites in 7 countries.

Detailed Summary

This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Czechia, Germany, Hungary, Italy, Poland, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2010
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2012
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.8 years ago

Interventions

Olaratumabbiological

15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8

Mitoxantronedrug

Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1 Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)

Prednisonedrug

5 mg orally (PO) twice daily (BID) on each day