4SC-201 (Resminostat) in Advanced Colorectal Carcinoma

Phase 1

Completed

• Conditions: Advanced Colorectal Carcinoma
• Interventions: Drug: 4SC-201(Resminostat); Drug: FOLFIRI

• Registration Number: NCT01277406
• Lead Sponsor: 4SC AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-14
• Primary Completion: 2013-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4SC-201+FOLFIRI	4SC-201(Resminostat)	-
4SC-201+FOLFIRI	FOLFIRI	-
FOLFIRI	FOLFIRI	-

Primary Outcome Measures

Name	Time	Method
Phase I: MTD of 4SC-201 (Resminostat) in combination with FOLFIRI by investigating safety, tolerability and pharmacokinetics
Phase II: Progression free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Phase I: Progression free survival (PFS)
Phase I: Progression free survival rate (PFSR) after 8 weeks (4 cycles) and every following 8 weeks (additional 4 cycles each)
Phase I: Time to Progression (TTP)
Phase I: Number of Objective Response (OR)
Phase I: Overall survival (OS)
Phase I: Duration of Response (DOR)
Phase II: Progression free survival rate (PFSR) after 8 weeks (4 cycles) and ever following 8 week (additional 4 cycles each)
Phase II: Time to Progression (TTP)
Phase II: Number of Objective Responses (OR)
Phase II: Duration of Response (DOR)
Phase II: Safety and tolerability data comprising vital signs, physical examinations, ECGs, clinical laboratory and adverse events
Phase II: Overall survival (OS)
Phase II: Pharmacokinetics: AUClast, AUCtau, cmax, tmax, t ½, CL/F of resminostat, Irinotecan (SN-38), 5-FU and folinic acid

Trial Locations

Locations (3)

KTB-Klinik für Tumorbiologie, Klinik für Internistische Onkologie; 🇩🇪 Freiburg, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany

Universitaetsklinikum Tuebingen; Med. Klinik und Poliklinik II; 🇩🇪 Tuebingen, Germany