check_circleStudy Completed

Colorectal Neoplasms

Bayer Identifier:

11656

ClinicalTrials.gov Identifier:

NCT00934882

EudraCT Number:

2008-007151-27

EU CT Number:

Not Available
Study to determine safety, pharmacokinetics, pharmacodynamics of BAY73-4506 in combination with mFOLFOX6 or FOLFIRI

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 99 Years
  • - 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
  • - 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.

Trial summary

Enrollment Goal
45
Trial Dates
August 2009 - April 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinik für Tumorbiologie FreiburgFreiburg, 79106, Germany
Completed
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Marienhospital Herne UniversitätsklinikHerne, 44625, Germany
Completed
Universitätsklinikum KölnKöln, 50937, Germany
Completed
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Klinikum Oldenburg gGmbHOldenburg, 26133, Germany
Terminated
Klinikum Mannheim gGmbHMannheim, 68167, Germany

Primary Outcome

  • Adverse Event Collection
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    yes
  • 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)
    date_rangeTime Frame:
    Cycle 1 and Cycle 2
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    Safety Issue:
    No

Secondary Outcome

  • Biomarker status
    date_rangeTime Frame:
    Screening, Cycle 1, Cycle 2, Cycle 3
    enhanced_encryption
    Safety Issue:
    no
  • Pharmacodynamic parameters
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    no
  • Tumor response
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    no

Trial design

Phase I, open-label, non-placebo controlled study to determine the safety, pharmacokinetics, and pharmacodynamics of BAY73-4506 in combination with mFOLFOX6 or FOLFIRI as first or second line therapy in patients with metastatic colorectal.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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