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

This study is ongoing, but not recruiting participants.
Information provided by:
National University Hospital, Singapore Identifier:
First received: August 25, 2010
Last updated: January 26, 2014
Last verified: January 2014
  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)

Condition Intervention Phase
Asian Colorectal Cancer Patients
Drug: Regorafenib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

Resource links provided by NLM:

Further study details as provided by National University Hospital, Singapore:

Study Start Date: January 2011
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
Please refer to this study by its identifier: NCT01189903

National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Boon Cher Goh, MBBS, MRCP National University Hospital, Singapore
  More Information

Publications: Identifier: NCT01189903     History of Changes
Other Study ID Numbers: CR01/18/10
Study First Received: August 25, 2010
Last Updated: January 26, 2014
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anticestodal Agents
Antiplatyhelmintic Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antinematodal Agents processed this record on April 22, 2014