Efficacy and the Safety of Regorafenib… | Clinical Trial

Key information

Conditions

Colorectal Adenocarcinoma

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CH Victor Dupouy, Argenteuil, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Metastatic colorectal cancer with histological proof
Measurable disease according RECIST 1.1
Age ≥ 70 years
ECOG ≤ 1
Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
Geriatric Questionnaires answered
Life-expectancy ≥ 3 months
Informed Consent Signed

Exclusion criteria

Not able to swallow tablets (crushed tablets are not allowed)
Previous treatment with regorafenib or other multikinase treatment
Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
Toxicity > grade 1 not resolved with previous treatment
Major surgery in the 28 days before the inclusion
Non cicatrized injury, ulcer or bone fracture
Congestive Cardiac insufficiency classe >2 (NYHA)
Unstable angor in the last 3 months
Myocardial Infraction in the 6 months before inclusion
HTA not controlled
Pheochromocytome
Arterial or venous thromboembolism in the past 6 months
Infection of grade > 2
VIH infection
B or C hepatitis necessiting a specific treatment
Cirrhosis
Suspicion of brain metastasis or brain metastasis
Haemorraghe ofgrade >3 in the last weeks
Symptomatic Pulmonary fibrosis
Proteinuria > grade 3
Malabsorption
Allergy know to the treatment or to one similar treatment or to one treatment component
Systemic anti-cancer drug during the study or the the last 4 weeks
Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
Social, psychological or medical condition which can interfere with the study participation

Treatment and study plan

Regorafenib 160 mg

Drug

Primary outcomes

Percentage of Patients With a Tumoral Control Rate at 2 Months

Time frame: 2 months after the start of treatment

Tumor control rate is defined as the percentage of patients with complete tumor response, partial tumor response, or tumor stability on regorafenib therapy at 2 months after initiation of therapy as determined by the investigator per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.1 criteria) for target lesions and assessed by CT-Scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stability : neither complete or partial response nor progression.

Secondary outcomes

Overall Survival

Time frame: Up to approximatively 1 year after the end of the treatment

Overall survival was defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news wastaken into account.

Overall survival was estimated also after the treatment stopped explaining the difference of time frame between this outcome and the adverse events outcome.

Sponsors and collaborators

Lead sponsor

Federation Francophone de Cancerologie Digestive

Other

Registry information

Official study title

Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

Acronym: REGOLD

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 2, 2016
Registry last updated: Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed