CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
GC1008drug
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/NCT01112293
NCT01112293Phase 2Completed
CompareCT.gov

A Phase II Trial of Anti-TGF Monoclonal Antibody (GC1008) in Relapsed Malignant Pleural Mesothelioma (MPM))

Abramson Cancer Center at Penn Medicine·interventional·Posted Apr 28, 2010·Updated Apr 10, 2020

In Brief

A Phase 2 clinical trial evaluating GC1008 for Pleural Malignant Mesothelioma. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This study is being conducted to evaluate the overall safety and effectiveness of an investigational drug, GC1008, in patients with mesothelioma. An investigational drug is one that has not been approved by the FDA. Approximately 40 people will be enrolled on this study at the University of Pennsylvania (Main Institution/Coordinating Site) and the University of Chicago (Participating Institution). We expect about 20 subjects to be enrolled at each institution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPleural Malignant Mesothelioma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartApr 1, 2010
Primary CompletionOct 1, 2012
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.2 years ago

Interventions

GC1008drug

GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.