ClinicalTrials.gov

History of Changes for Study: NCT01929616
Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) (RegARd-C)
Latest version (submitted June 21, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 21, 2013 None (earliest Version on record)
2 August 29, 2013 Arms and Interventions and Study Status
3 October 8, 2013 Contacts/Locations and Study Status
4 May 13, 2014 Study Status
5 November 26, 2014 Recruitment Status, Study Status and Contacts/Locations
6 May 19, 2015 Study Status
7 February 23, 2016 Study Status
8 March 7, 2017 Study Status
9 June 21, 2019 Recruitment Status, Study Status and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT01929616
Submitted Date:  August 21, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2012-005655-16 EUDRACT
Brief Title: Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C) (RegARd-C)
Official Title: Regorafenib Assessment in Refractory Advanced Colorectal Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2013
Overall Status: Recruiting
Study Start: August 2013
Primary Completion: September 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: July 28, 2013
First Submitted that
Met QC Criteria:
August 21, 2013
First Posted: August 28, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 21, 2013
Last Update Posted: August 28, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Jules Bordet Institute
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
Detailed Description:

The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory.

Secondary objectives:

  • To analyze PFS and response rate (RR) in relationship with the same covariates as for OS
  • To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study population.
  • To assess the Disease control rate (DCR = Complete response [CR] + partial response [PR] + stable disease [SD])
  • To compare the relative benefit (OS, PFS) of regorafenib according to history of treatment with bevacizumab.
Open or close this module Conditions
Conditions: Advanced Chemorefractory Colorectal Adenocarcinoma
Keywords: adenocarcinoma, colorectal,regorafenib
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 124 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Regorafenib
A treatment cycle is defined as a 4 weeks period. Regorafenib will be administered once a day orally at a dose of 160 mg (4 tablets of 40 mg), for 3 weeks.
Drug: regorafenib
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: 2 years from first patient in ]

Secondary Outcome Measures:
1. Occurence of Adverse events
[ Time Frame: Every 28 days till 28 days after stopping therapy. An average of 2 months is expected. ]

Assessment of safety will follow the WHO guidelines and classified according to NCI-CTCAE v. 4.0 and will be performed every 28 days until 28 days (safety follow up visit) after stopping therapy. Reasons for stopping therapy may include progression of disease or unbearable toxicities, or patient's decision.
2. Evaluation of tumour response
[ Time Frame: Every 2 months till progression of the disease. An average of 2 months is expected. ]

RECIST 1.1-based radiological assessment (CT or MRI) will be made every 2 cycles, starting at day 28 of the second cycle till demonstration of progressive disease. An average of 2 months is expected.
3. Metabolic response assessed by FDG PET
[ Time Frame: 2 FDGPET will be perfomed : at Baseline (day 0) and at D14 ]

FDGPET will be done twice during the study course : at baseline (at day 0, before treatment begin) and after 2 weeks.
4. Molecular aberrations
[ Time Frame: at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected. ]

Genetic, epigenetic and molecular aberrations will be investigated using gene expression profiling, RNA and exome sequencing, and methylation profiling on the tumor biopsies and repeated blood samples collected during the trial. The relationship between the molecular aberrations,the patient's outcome (PFS, OS) and with metabolic response after treatment with regorafenib will be studied.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Histologically proven colorectal adenocarcinoma that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
  2. Age ≥ 18 years.
  3. Life expectancy of greater than 12 weeks.
  4. ECOG performance status ≤ 1.
  5. Participants must have normal organ and bone marrow function as defined below:
    • Leukocytes >3,000/mcL,with an absolute neutrophil count >1,500/mcL, platelets >100,000/mcL, Hb >or=9g/dl.
    • Total bilirubin≤1.5×institutional ULN.
    • AST/ALT/P-Alk levels ≤ 2.5 × institutional ULN (≤5x institutional ULN in case of liver metastatic involvement).
    • Lipase ≤1.5 institutional ULN.
    • coagulation tests ≤ 1.5 x institutional ULN.
    • Creatinine ≤ 1.5× institutional ULN or creatinine clearance >30mL/min according to the Modified Diet in Renal Disease (MDRD) abbreviated formula.
  6. Women of childbearing potential and men must agree to use adequate contraception prior to study entry, until at least 3 months after the last study drug administration.
  7. Signed Written Informed Consent (IC).
  8. Presence of a previously collected or freshly obtained at the time of study entry frozen metastatic tumor biopsy in a FDG-PET targetable lesion.
  9. Presence of at least one metabolically measurable tumoral lesion on FDG PET-CT

Exclusion Criteria:

  1. Prior treatment with sorafenib or regorafenib
  2. Patients with previous cancer that is not disease-free for at least for 5 years prior to registration, EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
  3. Participants who have had a major surgery, chemotherapy or radiotherapy within 4 weeks prior to entering the study.
  4. Unresolved toxicity higher than NCI-CTCAE (version 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ≤Grade 2.
  5. Participants receiving any experimental agents.
  6. Participants with known brain metastases.
  7. Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
  8. Any hemorrhage or bleeding event NCI-CTCAE v.4 Grade >or= 3 within 4 weeks prior to the start of study medication.
  9. Uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure (New York Heart Association (NYHA)class> or=2), unstable angina pectoris, cardiac arrhythmia requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
  10. Uncontrolled hypertension.
  11. Patients with seizure disorder requiring medication.
  12. Any history of organ allograft.
  13. Pleural effusion or ascites affecting respiration.
  14. Uncontrolled diabetes.
  15. Non-healing wound, ulcer, or bone fracture.
  16. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
  17. Interstitial lung disease with ongoing signs and symptoms.
  18. Renal failure requiring hemo-or peritoneal dialysis.
  19. Dehydration NCI-CTCAE v.4 grade >1.
  20. Medical,psychological or social conditions that may interfere with the patient's ability to understand informed consent and participation in the study or evaluation of the study results.
  21. Known hypersensitivity to the study drug or excipients in the formulation.
  22. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
  23. Pregnant or lactating women.
  24. Subjects unable to swallow oral medications.
Open or close this module Contacts/Locations
Central Contact Person: Alain Hendlisz, MD
Telephone: +32 (0) 2 541 72 09
Email: alain.hendlisz@bordet.be
Study Officials: Alain Hendlisz, MD
Study Chair
Jules Bordet Institute
Locations: Belgium
Jules Bordet Institute
[Recruiting]
Brussels, Belgium, 1000
Contact:Contact: Rachel Ho rachel.ho@bordet.be
Contact:Principal Investigator: Alain Hendlisz, MD
Hopital Erasme
[Not yet recruiting]
Brussels, Belgium, 1070
Contact:Principal Investigator: Raphaël Maréchal, MD
Cliniques Universitaires Saint Luc
[Not yet recruiting]
Brussels, Belgium
Contact:Contact: Marc VandenEynde, MD marc.vandeneynde@uclouvain.ac.be
Contact:Principal Investigator: Marc Vandeneynde, MD
Grand Hopital de Charleroi
[Not yet recruiting]
Charleroi, Belgium, 6000
Contact:Principal Investigator: Javier Javier Carrasco, MD
UZ Ghent
[Not yet recruiting]
Ghent, Belgium
Contact:Contact: Karen Geboes, MD, PhD Karen.Geboes@uzgent.be
Contact:Principal Investigator: Karen Geboes, MD, PhD
AZ groeninge
[Not yet recruiting]
Kortrijk, Belgium, 8500
Contact:Principal Investigator: Philippe Vergauwe, MD
Centre Hospitalier Universitaire de Liège
[Not yet recruiting]
Liège, Belgium, 4000
Contact:Principal Investigator: Daniel Van Daele, MD
Clinique St Joseph
[Not yet recruiting]
Liège, Belgium, 4000
Contact:Principal Investigator: Gauthier Demolin, MD
Centre hospitalier de Jolimont
[Not yet recruiting]
Lobbes, Belgium, 6540
Contact:Principal Investigator: Thierry Delaunoit, MD
CHU Ambroise Paré
[Not yet recruiting]
Mons, Belgium, 7000
Contact:Principal Investigator: Stephane Holbrechts, MD
Centre Hospitalier Régional de Namur
[Not yet recruiting]
Namur, Belgium, 5000
Contact:Principal Investigator: Thierry De Grez, MD
Clinique et Maternité Sainte Elisabeth
[Not yet recruiting]
Namur, Belgium, 5000
Contact:Principal Investigator: Jean-Charles Dr Jean-Charles Goeminne, MD
Clinique Saint Pierre
[Not yet recruiting]
Ottignies, Belgium, 1340
Contact:Principal Investigator: Jean charles Coche, MD
Hartziekenhuis Roeselare-Menen (HHRM)
[Not yet recruiting]
Roeselare, Belgium, 8800
Contact:Principal Investigator: Jochen Decaestecker, MD
AZ Turnhout
[Not yet recruiting]
Turnhout, Belgium, 2300
Contact:Principal Investigator: Jos Janssens, MD
Cliniques Universitaires UCL de Mont-Godinne
[Not yet recruiting]
Yvoir, Belgium, 5530
Contact:Principal Investigator: Lionel Dhondt, MD
Belgium, Edegem
UZA
[Not yet recruiting]
Antwerpen, Edegem, Belgium, 2650
Contact:Contact: Marc Peeters, MD, PhD marc.peeters@UZA.be
Contact:Principal Investigator: Marc Peeters, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services