NCT01277406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

January 10, 2011

Last Update Submit

March 31, 2015

Conditions

Advanced Colorectal Carcinoma

Keywords

Colorectal CarcinomaResminostatHDAC4SC-201Phase IPhase II

Outcome Measures

Primary Outcomes (2)

  • Phase I: MTD of 4SC-201 (Resminostat) in combination with FOLFIRI by investigating safety, tolerability and pharmacokinetics

  • Phase II: Progression free survival (PFS)

Secondary Outcomes (13)

  • 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)

  • +8 more secondary outcomes

Study Arms (2)

4SC-201+FOLFIRI

EXPERIMENTAL
Drug: 4SC-201(Resminostat)Drug: FOLFIRI

FOLFIRI

ACTIVE COMPARATOR
Drug: FOLFIRI

Interventions

4SC-201(Resminostat)DRUG

oral administration

4SC-201+FOLFIRI
FOLFIRIDRUG

i.v. administration

4SC-201+FOLFIRIFOLFIRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed advanced stage colorectal carcinoma
  • Documented progression after precedent treatment according to RECIST criteria
  • ECOG performance status 0 - 2
  • Live expectancy of 12 weeks or more
  • Patients must have previously received treatment with 5-FU alone or in combination with other anti-tumor medications
  • Patients foreseen for chemotherapy with FOLFIRI in second or further line treatment

You may not qualify if:

  • Patients who have received previous treatment with an HDAC inhibitor
  • Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study
  • Therapy with agents known to prolong the QT interval, such as certain antibiotics (e.g. erythromycin, clarithromycin), antidepressants (e.g. doxepin, amitryptiline) or neuroleptics (e.g. haloperidol, clozapine)
  • Therapy with strong CYP3A4 inhibitors (e.g. ketoconazole) or inductors (e.g. carbamazepine, phenytoin, St. John's Wort)
  • Patients with a confirmed QTcF \> 480 ms, or a history of additional risk factors for Torsades de Pointes
  • Major surgery within the last 4 weeks
  • Histologically or cytologically confirmed advanced stage colorectal carcinoma
  • Documented progression after precedent treatment according to RECIST criteria
  • ECOG performance status 0 - 2
  • Live expectancy of 12 weeks or more
  • Patients must have previously received treatment with 5-FU alone or in combination with other anti-tumor medications
  • Patients foreseen for chemotherapy with FOLFIRI in second line treatment
  • Patients who have received previous treatment with an HDAC inhibitor
  • Anticipation of need for a major surgical procedure or radiation therapy (RT) during the study
  • Therapy with agents known to prolong the QT interval, such as certain antibiotics (e.g. erythromycin, clarithromycin), antidepressants (e.g. doxepin, amitryptiline) or neuroleptics (e.g. haloperidol, clozapine)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

KTB-Klinik für Tumorbiologie, Klinik für Internistische Onkologie

Freiburg im Breisgau, Germany

Location

University of Heidelberg

Heidelberg, Germany

Location

Universitaetsklinikum Tuebingen; Med. Klinik und Poliklinik II

Tübingen, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IFL protocol

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Dirk Jäger, Prof. Dr.

    Medical Oncology National Centre for Tumor Diseases (NCT); University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2011

First Posted

January 14, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

DE(3)