Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)

NCT01929616 | Completed Phase 2 DMC

• 1 other identifier: 2012-005655-16 EUDRACT
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 17

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.

Conditions

Advanced Chemorefractory Colorectal Adenocarcinoma

Keywords

adenocarcinoma, colorectal,regorafenib

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  2 years from first patient in

Secondary Outcomes (4)

• Occurence of Adverse events

  Every 28 days till 28 days after stopping therapy. An average of 2 months is expected.

• Evaluation of tumour response

  Every 2 months till progression of the disease. An average of 2 months is expected.

• Metabolic response assessed by FDG PET

  2 FDGPET will be perfomed : at Baseline (day 0) and at D14

• Molecular aberrations

  at day 0 (before treatment begins) and at D14, then repeated every 2 months until progression. An average of 2 months is expected.

Study Arms (1)

Regorafenib

EXPERIMENTAL

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

Interventions

regorafenib DRUG

Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.

Also known as: stivarga (registred name)

Regorafenib

Eligibility Criteria

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

You may qualify if:

• Histologically proven colorectal adenocarcinoma that is metastatic or unresectable and for which standard treatments do not exist or are no longer effective.
• Age ≥ 18 years.
• Life expectancy of greater than 12 weeks.
• ECOG performance status ≤ 1.
• 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.
• 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.
• Signed Written Informed Consent (IC).
• Presence of a previously collected or freshly obtained at the time of study entry frozen metastatic tumor biopsy in a FDG-PET targetable lesion.
• Presence of at least one metabolically measurable tumoral lesion on FDG PET-CT

You may not qualify if:

• Prior treatment with sorafenib or regorafenib
• 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 \[Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)\].
• Participants who have had a major surgery, chemotherapy or radiotherapy within 4 weeks prior to entering the study.
• 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.
• Participants receiving any experimental agents.
• Participants with known brain metastases.
• Bleeding diathesis, history of cardiovascular ischemic disease or cerebrovascular incident within the last six months.
• Any hemorrhage or bleeding event NCI-CTCAE v.4 Grade \>or= 3 within 4 weeks prior to the start of study medication.
• 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).
• Uncontrolled hypertension.
• Patients with seizure disorder requiring medication.
• Any history of organ allograft.
• Pleural effusion or ascites affecting respiration.
• Uncontrolled diabetes.
• Non-healing wound, ulcer, or bone fracture.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (17)

UZA

Antwerp, Edegem, 2650, Belgium

Location

Jules Bordet Institute

Brussels, 1000, Belgium

Location

Hopital Erasme

Brussels, 1070, Belgium

Location

Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Grand Hopital de Charleroi

Charleroi, 6000, Belgium

Location

UZ Ghent

Ghent, Belgium

Location

AZ groeninge

Kortrijk, 8500, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Clinique St Joseph

Liège, 4000, Belgium

Location

Centre hospitalier de Jolimont

Lobbes, 6540, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

Centre Hospitalier Régional de Namur

Namur, 5000, Belgium

Location

Clinique et Maternité Sainte Elisabeth

Namur, 5000, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Hartziekenhuis Roeselare-Menen (HHRM)

Roeselare, 8800, Belgium

Location

AZ Turnhout

Turnhout, 2300, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Publications (2)

• Charette N, Vandeputte C, Ameye L, Bogaert CV, Krygier J, Guiot T, Deleporte A, Delaunoit T, Geboes K, Van Laethem JL, Peeters M, Demolin G, Holbrechts S, Flamen P, Paesmans M, Hendlisz A. Prognostic value of adipose tissue and muscle mass in advanced colorectal cancer: a post hoc analysis of two non-randomized phase II trials. BMC Cancer. 2019 Feb 12;19(1):134. doi: 10.1186/s12885-019-5319-8.

  PMID: 30744591 DERIVED

• Hendlisz A, Deleporte A, Vandeputte C, Charette N, Paesmans M, Guiot T, Garcia C, Flamen P. Regorafenib assessment in refractory advanced colorectal cancer: RegARd-C study protocol. BMJ Open. 2015 Mar 9;5(3):e007189. doi: 10.1136/bmjopen-2014-007189.

  PMID: 25753361 DERIVED

MeSH Terms

Conditions

Adenocarcinoma

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alain Hendlisz, MD

  Jules Bordet Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2013
• First Posted: August 28, 2013
• Study Start: August 1, 2013
• Primary Completion: May 13, 2016
• Study Completion: June 17, 2019
• Last Updated: June 25, 2019

Record last verified: 2017-03

Locations

BE (17)