NCT00934882

Brief Summary

This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506 as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic CRC. It will also determine the impact of the combined administration on the concentration of drugs over time (pharmacokinetics) of BAY73-4506, oxaliplatin, 5 FU, and irinotecan. This study will be conducted at approximately 5 - 8 study centers in Germany. Up to 60 patients will be enrolled into this study to ensute that at least 12 - 15 patients for each combination regimen can be evaluated for safety and pharmacokinetics. For this reason a minimum of 20 patients will receive mFOLFOX6 in combination with BAY73-4506 and at least 20 patients will receive FOLFIRI in combination with BAY73-4506.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

7 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

First Submitted

Initial submission to the registry

July 3, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

2.7 years

First QC Date

July 3, 2009

Last Update Submit

May 30, 2014

Conditions

Colorectal Neoplasms

Keywords

Colorectal cancerTargeted therapyMulti-kinase inhibitorFOLFOXFOLFIRI

Outcome Measures

Primary Outcomes (2)

  • Adverse Event Collection

    3 years

  • Effect of BAY73-4506 on the pharmacokinetics of mFOLFOX6 and FOLFIRI (Cmax, AUC, through concentration of BAY73-4506 and Cmax, AUC of Platinum, Irinotecan and its metabolite SN-38, 5-Flourouracil)

    Cycle 1 and Cycle 2

Secondary Outcomes (3)

  • Biomarker status

    Screening, Cycle 1, Cycle 2, Cycle 3

  • Pharmacodynamic parameters

    3 years

  • Tumor response

    3 years

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Regorafenib (BAY73-4506)

Interventions

Regorafenib (BAY73-4506)DRUG

Administration of the multi-kinase inhibitor BAY73-4506 (160 mg once daily from Day 4 to Day 10 and from Day 18 to Day 24) as oral treatment in combination with the chemotherapy regimen mFOLFOX6 or FOLFIRI in patients with metastatic Colorectal Cancer

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological documentation of adenocarcinoma of the colon or rectum.
  • At least 1 measurable lesion as per RECIST
  • ECOG Performance Status of 0 - 1
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, liver, and renal function

You may not qualify if:

  • More than 1 previous chemotherapy for Colorectal Cancer. Adjuvant chemotherapy for Colorectal Cancer (Stage I, II, II) is permitted, if the adjuvant therapy ended \>6 month before screening.
  • Previous FOLFOX treatment for patients who will be included in the mFOLFOX6 cohort apart from FOLFOX treatment in an adjuvant setting.
  • Previous FOLFIRI treatment for patients who will be included in the FOLFIRI cohort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Unknown Facility

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Unknown Facility

Oldenburg, Lower Saxony, 26133, Germany

Location

Unknown Facility

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Unknown Facility

Herne, North Rhine-Westphalia, 44625, Germany

Location

Unknown Facility

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • Schultheis B, Folprecht G, Kuhlmann J, Ehrenberg R, Hacker UT, Kohne CH, Kornacker M, Boix O, Lettieri J, Krauss J, Fischer R, Hamann S, Strumberg D, Mross KB. Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study. Ann Oncol. 2013 Jun;24(6):1560-7. doi: 10.1093/annonc/mdt056. Epub 2013 Mar 13.

    PMID: 23493136RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 8, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

DE(7)