Regorafenib in Frail and/or Unfit for Chemotherapy Patients With Metastatic Colorectal Cancer

NCT01875380 | Completed Phase 2

• 2 other identifiers: TTD-13-012013-000236-94
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of single-agent regorafenib in the first line treatment of frail and/or unfit for polychemotherapy patients with metastatic colorectal cancer (mCRC)

Conditions

Colorectal Neoplasms; Metastatic Disease

Keywords

metastatic colorectal cancer; frail and unfit patient; regorafenib

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate at 6 months

  6 months

Secondary Outcomes (15)

• Objective response rate

  30 months

• Disease control rate

  30 months

• Time to response

  30 months

• Time to progression

  30 months

• Progression-free survival

  30 months

Other Outcomes (2)

• microRNA expression levels and their correlation with tumour-efficacy parameters (objective response rate, progression-free survival and overall survival), as well as toxicity

  30 months

• Biomarkers associated with cell and tumour growth and/or the mechanism of action of regorafenib and their correlation with patients' clinical progression for efficacy and safety parameters.

  30 months

Study Arms (1)

Regorafenib

EXPERIMENTAL

Regorafenib will be administered orally at the initial dosage of 160 mg per day for 3 weeks,followed by one week of rest, according to the 3/1 regimen.

Drug: Regorafenib

Interventions

Regorafenib DRUG

Regorafenib

Eligibility Criteria

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

You may qualify if:

• Signing of the informed consent form.
• The patient must be able to understand the information and state expressly his or her desire to take part in the study.
• Age \> 18 years.
• Patients with histologically or cytologically documented adenocarcinoma of the colon or rectum who have not been previously treated systemically for advanced disease. Patients can have received fluoropyrimidine-based adjuvant therapy if the last dose was taken at least 6 months prior to study entry.
• Patients who are frail and/or unfit for polychemotherapy owing to the presence of one or more of the following criteria:
• Patients with dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease.
• Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment:
• Congestive heart failure
• Other chronic cardiovascular diseases
• Chronic obstructive pulmonary disease
• Cerebrovascular disease
• Peripheral neuropathy
• Chronic kidney failure
• Hypertension
• Diabetes mellitus

You may not qualify if:

• Prior treatment with regorafenib.
• Assignment prior to treatment during this study. Patients who are permanently withdrawn from participation in the study treatment will not be allowed to return to it.
• Presence or history of brain metastases or meningeal tumours.
• Major surgery, open biopsy or traumatic injury within 28 days prior to the start of patient treatment with the study medication.
• Extended-field radiotherapy within 4 weeks prior to randomisation or limited-field radiotherapy in the previous 2 weeks. Patients must have recovered from all treatment-related toxicities.
• Pregnant or breastfeeding women. Women of childbearing age must use adequate contraception. Women of childbearing age must have a negative pregnancy test within 7 days prior to starting with the study medication.
• Active congestive heart failure class 2 or higher on the New York Heart Association (NYHA) scale.
• Unstable angina (angina symptoms at rest), new-onset angina (having appeared in the past 3 months) or acute myocardial infarction that has occurred in the 6 months prior to starting with the study medication.
• Cardiac arrhythmias that require anti-arrhythmic therapy (only beta blockers and digoxin would be allowed as concomitant medication for these patients).
• Uncontrolled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg) despite proper medical management.
• Patients with phaeochromocytoma.
• Pleural effusion or ascites that cause breathing difficulties (dyspnoea of grade ≥2 of the CTC).
• Accidents (including transient ischaemic attacks), deep vein thrombosis or pulmonary thromboembolism that have occurred in the 6 months prior to starting with the study medication.
• Active infection \> grade 2 based on the NCI CTC, v. 4.0.
• Human immunodeficiency virus (HIV) infection.

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Bayer: collaborator

Study Sites (1)

Spanish Cooperative Group for Digestive Tumour Therapy (TTD)

Madrid, 28046, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alfredo Carrato, MD-PhD

  Ramon y Cajal University Hospital

  STUDY CHAIR

• Enrique Grande, MD

  Ramon y Cajal University Hospital

  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: June 7, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

ES (1)