Phase 2
Completed N=43
Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years With a Metastatic Colorectal Adenocarcinoma .
Source: ClinicalTrials.gov NCT02788006 ↗Enrolled (actual)
43
Serious AEs
40.5%
Results posted
Feb 2024
Primary outcomePrimary: Percentage of Patients With a Tumoral Control Rate at 2 Months — 31.4 Percentage of patients
Summary
Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With a Tumoral Control Rate at 2 Months |
31.4 | — |
| SECONDARY Overall Survival |
7.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02788006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.