metastatic colorectal cancer MedDRA version: 16.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: NEXAVAR
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SORAFENIB
CAS Number: 284461-73-0
Other descriptive name: protein kinase inhibitor
Concentration unit: mg milligram(s)
Conce
Sponsors
Centre Val d’Aurelle - Paul Lamarque
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female = 18 years old - Histologically confirmed diagnosis of colorectal cancer - Asymptomatic or resected primary tumor - Metastatic colorectal cancer not eligible for curative surgery - At least one target lesion: - Unidimensionally measurable on cross-sectional imaging - In an area not previously irradiated - Disease progression after failure of active drugs (5-Fu or 5-Fu prodrugs, irinotecan, oxaliplatin, bevacizumab) - WHO performance status = 2 - Confirmation of KRAS mutation in codons 12 or 13 in the primary tumor or metastases - Total bilirubin = 1.5 ULN, ALT or AST = 2.5 ULN (or 3 months - Informed consent signed prior any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of Gilbert’s syndrome - Symptomatic brain metastases or carcinomatous meningitis - Bone-only metastases - History or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer) - Prior surgery or radiotherapy within 4 weeks before entering the study - Cardiac arrhythmia requiring treatment (except for beta-blockers and digoxin), unstable cardiac disease, myocardial infarction within the previous 6 months, > grade II NYHA heart failure, uncontrolled hypertension - History of epileptic seizures requiring long-term anticonvulsant therapy - History of organ transplantation with use of immunosuppression therapy - Severe bacterial or fungal infection (Grade > 2 NCI-CTCAE v.3.0) - HIV infection - Long-term use of CYP 3A4 enzyme-inducing agents such as rifampicin, St. John's Wort (hypericum perforatum), phenytoin, carbamazepine, phenobarbital, dexamethasone, and ketoconazole - Pregnant or breastfeeding women - Bowel malabsorption or extended bowel resection that could affect the absorption of sorafenib, occlusive syndrom, inability to take oral medications - Inflammatory bowel disease with chronic diarrhea (NCI N+Bethesda = 1.2g) - Participation in another clinical trial 30 days prior to study entry - Concurrent treatment with any other investigational product or anticancer therapy (except for irinotecan or sorafenib) - Psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the median progression free survival defined as the time from randomization to disease progression according to RECIST criteria (Version 1.1) or death from any cause ;Secondary Objective: - Disease control rate and response rate - Treatment-related toxicity (NCI CTC V4.0) - Overall survival - Quality of life;Primary end point(s): The primary assessment criterion is the median progression free survival (PFS), evaluated according to the RECIST criteria (v1.1) by chest-abdomen-pelvis CT-scan every 8 weeks. A complete or partial response will have to be confirmed 4 weeks after the initial observation. All responses will be reviewed by a panel of independent radiologists. | — |
Countries
France
Contacts
Public ContactDr Jean-Pierre BLEUSE
Centre Val d’Aurelle - Paul Lamarque
Outcome results
None listed