Clinical Trials Directory

Trials / Completed

CompletedNCT01277406

4SC-201 (Resminostat) in Advanced Colorectal Carcinoma

A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Resminostat (4SC-201) in Combination With a Second-line Treatment in Patients With K-ras Mutated Advanced Colorectal Carcinoma

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
17 (actual)
Sponsor
4SC AG · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201 (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal carcinoma.

Conditions

Interventions

TypeNameDescription
DRUG4SC-201(Resminostat)oral administration
DRUGFOLFIRIi.v. administration

Timeline

Start date
2011-01-01
Primary completion
2013-02-01
Completion
2015-02-01
First posted
2011-01-14
Last updated
2015-04-01

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT01277406. Inclusion in this directory is not an endorsement.