Mode
Text Size
Log in / Sign up
Phase 2 Completed N=43 Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

Back to search