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

Primary Purpose

Asian Colorectal Cancer Patients

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Regorafenib
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asian Colorectal Cancer Patients

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • National University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 25, 2010
Last Updated
January 26, 2014
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01189903
Brief Title
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Official Title
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore

4. Oversight

5. Study Description

Brief Summary
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) 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asian Colorectal Cancer Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Regorafenib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boon Cher Goh, MBBS, MRCP
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
10854137
Citation
Goh BC, Fleming GF, Janisch L, Vogelzang NJ, Stadler WM, Ratain MJ. Development of a schedule-dependent population pharmacodynamic model for rhizoxin without quantitation of plasma concentrations. Cancer Chemother Pharmacol. 2000;45(6):489-94. doi: 10.1007/s002800051024.
Results Reference
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PubMed Identifier
10430263
Citation
Vokes EE, Goh BC, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ. A Phase I study of raltitrexed and paclitaxel given every 3 weeks to patients with solid tumors. Cancer. 1999 Aug 1;86(3):528-32.
Results Reference
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Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients

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