Identification of Predictive Biomarker of Regorafenib in Refractory Colorectal Cancer

NCT01996969 | Completed DMC

• 1 other identifier: Regorafenib biomarker
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

Regorafenib is a valuable treatment option for metastatic colorectal cancer patients who have progressed after prior standard treatments. Prior progression-free survival data suggest that there could be a distinct subgroup of patients that may benefit from regorafenib. The aim of this study is to identify predictive biomarker of regorafenib in terms of its efficacy.

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer; refractory; regorafenib; biomarker; gene sequencing

Outcome Measures

Primary Outcomes (1)

• Predictive biomarker in terms of disease control rate

  This study aims at identifying potential molecular subgroup of colorectal cancer that may benefit from regorafenib treatment in terms of disease control rate.

  1 year

Secondary Outcomes (7)

• Disease control rate

  1 year

• Progression-free survival

  1 year

• Overall survival

  1 year

• number of participants with adverse events

  1 year

• Progression-free survival according to biomarker status

  1 year

Study Arms (1)

Regorafenib

OTHER

This study is a single arm study with biomarker analysis

Drug: Regorafenib

Interventions

Regorafenib DRUG

Regorafenib will be given 160mg once daily for 3 weeks, followed by a 1 week rest. Treatment will be continued until disease progression or unacceptable toxicity occurs. Response evaluation (CT scans) will be performed every 2 cycles.

Regorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent obtained before any study-specific procedures.
• Age ≥ 20
• Pathologically confirmed metastatic adenocarcinoma of colon or rectum
• Failure of standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Failure is defined as progression during or within 3 months following the last administration of therapy. Patients who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent before progression of disease will also be allowed into the study. Patients treated with oxaliplatin in an adjuvant setting who have progressed during or within 6 months of completion of adjuvant therapy are regarded as failure of oxaliplatin. Patients may or may not have received bevacizumab or cetuximab.
• Measurable or nonmeasurable disease according to RECIST criteria, version 1.1.
• Adequate tissue for gene sequencing (surgical FFPE specimen or fresh-frozen biopsy specimen)
• ECOG PS 0 or 1
• Life expectancy of at least 3 months
• Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 14 days of starting to study treatment
• Total bilirubin ≤1.5 × ULN
• Alanine aminotransferase and aspartate aminotransferase ≤2 × ULN (≤5 × ULN for patients with liver involvement of cancer)
• Amylase and lipase ≤1.5 × ULN
• Serum creatinine ≤1.5 × ULN
• Glomerular filtration rate ≥30 ml/min/1.73 m2 according to the Modified Diet in Renal Disease abbreviated formula
• International normalised ratio (INR) and partial thromboplastin time (PTT) ≤1.5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists.

You may not qualify if:

• Prior treatment with regorafenib
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
• Pregnancy or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed a maximum of 7 days before start of treatment
• Congestive heart failure of NYHA class 2 or worse
• Unstable angina, new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug
• Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
• Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic \>90 mmHg despite optimal medical management)
• Arterial or venous thrombotic or embolic events within the 6 months before start of study medication
• Ongoing infection higher than NCI-CTCAE v4.0 grade 2
• Known history of HIV infection
• Active hepatitis B or C virus infection
• Seizure disorder requiring medication
• Symptomatic metastatic brain or meningeal tumors
• History of organ allograft
• Non-healing wound, ulcer, or bone fracture

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Bayer: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tae-You Kim, M.D., Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Sae-Won Han, M.D.,Ph.D

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 27, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: May 1, 2016
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

KR (1)