tanzisertib (CC 930) - BMS
(-) A study to characterize the safety, PK and biological activity of CC-930 in idiopathic pulmonary fibrosis (IPF) (clinicaltrials.gov) - Jul 16, 2012 - P2, N=28; Recruiting -> Terminated (The benefit/risk profile does not support continuation of this study) 
Trial termination • Fibrosis
http://clinicaltrials.gov/ct2/show/NCT01203943
 
Jul 16, 2012
 
This study has been terminated. ( The benefit/ risk profile does not support continuation of this study. ) First Received on September 15, 2010.   Last Updated on July 16, 2012   History of Changes Sponsor: Celgene Corporation Information provided by (Responsible Party): Celgene Corporation ClinicalTrials.gov Identifier: NCT01203943   Purpose The primary purpose of the study is to evaluate the safety and PK profile of CC-930 in idiopathic pulmonary fibrosis patients. Condition  Idiopathic Pulmonary Fibrosis Pulmonary Fibrosis Fibrosis Interstitial Lung Disease Lung Diseases, Interstitial Intervention Drug: CC-930 Other: Placebo Phase Phase 2 Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Phase 2 Sequential, Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetic and Biological Activity of CC-930 in Idiopathic Pulmonary Fibrosis (IPF) Resource links provided by NLM: MedlinePlus related topics: Interstitial Lung Diseases Pulmonary Fibrosis U.S. FDA Resources Further study details as provided by Celgene Corporation: Primary Outcome Measures:     Evaluate the type, frequency, severity, and relationship of adverse events to CC-930 (through laboratory, electrocardiogram [ECG], physical exam, change in pulmonary function tests or other changes) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ] Secondary Outcome Measures:     Pharmacokinetics (PK) of CC-930 and metabolite M18 in plasma [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]     Long-term safety [ Time Frame: Up to 56 weeks ] [ Designated as safety issue: Yes ] Enrollment: 28 Study Start Date: January 2011 Estimated Study Completion Date: November 2013 Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)