Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

January 26, 2014 updated by: National University Hospital, Singapore

  1. Primary Endpoints

    • Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis.
    • Evaluation of potential relationships between biomarker data and clinical activity.
    • Evaluation of a novel biomarker technology (Prometheus COPIA platform)

  2. Secondary Endpoints

    • Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells.
    • Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells.
    • Patient safety data
    • Pharmacokinetics of regorafenib
    • Changes in tumor metabolic activity as measured by PET CT scan (optional)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically proven metastatic colorectal adenocarcinoma that is refractory to standard therapy and not amenable to surgery with curative intent.

  • Tumor characteristics:

    • At least one lesion that is suitable for a repeated biopsy; eg. subcutaneous nodule, skin lesion, rectal tumor, colonic mass easily reached by colonoscopy, peritoneal masses at least 3cm in maximum diameter that are easily assessable by image guided core biopsy.
    • For liver lesions, more superficially located lesions at least 3cm in maximum dimension with a rim of normal liver tissue, assessable safely by image guided core biopsy as determined by an experienced interventional radiologist.
  • Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 (see Appendix 10.4).
  • Adequate bone marrow function (absolute neutrophil count =1,500/mm3; platelet count =100000/mm3; hemoglobin =9g/dl

  • Adequate liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:

    • Total bilirubin < 1.5 x the upper limit of normal (ULN).
    • Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (< 5 x ULN for patients with liver involvement of their cancer).
    • Amylase and lipase < 1.5 x the ULN
    • Serum creatinine < 1.5 x the ULN.
    • Glomerular filtration rate (GFR) = 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal disease) abbreviated formula
  • Prothrombin time, international normalized ratio (INR) and partial thromboplastin time less than or equal to 1.2 times the ULN.
  • Male or female at least 21 years of age.

  • A female subject is eligible to enter and participate in the study if she is:

    • Non-childbearing potential (ie. physiologically incapable of becoming pregnant) including any women who:
    • Has had a hysterectomy or
    • Has bilateral oophorectomy (ovariectomy) or
    • Has bilateral tubal ligation or
    • Is postmenopausal (demonstrate total cessation of menses for greater than or
    • Childbearing potential, has a negative serum or urine pregnancy test at screening, agrees to one of the following: double barrier contraception or abstinence.
  • Predicted life expectancy of at least 12 weeks.
  • Resting oxygen saturation greater than 92% on room air.
  • Written informed consent.
  • Able to swallow and retain oral medication.
  • Prothrombin time (PT), International Normalized Ratio for PT (PT INR), and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) within normal limits.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Boon Cher Goh, MBBS, MRCP, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR01/18/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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