malignant solid tumors
Conditions
Interventions
Combination of sorafenib with sirolimus (dose escalating study)
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with histological or cytological confirmed advanced solid tumor, which is refractory to standard therapies or for which no standard therapy exists and for which there is a rationale for the therapeutic use of a combination of sorafenib and sirolimus (especially metastic RCC, malignant melanoma, HCC, NSCLC, pancreatic cancer, hormone refractory prostate cancer). 2. Men or women of at least 18 years 3. Patients who have an ECOG status of 0 or 1 4. Patients who have a life expectancy of at least 12 weeks 5. Adequate bone marrow, liver and renal function
Exclusion criteria
Exclusion criteria: 1. History of serious cardiac disease 2. Active clinically serious bacterial, viral or fungal infections (> grade 2). 3. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. 4. Clinically symptomatic brain or meningeal metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Critria for evaluation Safety profile The primary end point is to identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies. Evaluation of DLT*s will be done. Adverse events will be scored using CTC AE v3. Efficacy There will be a descriptive analysis of proportion of patients with response or stable disease. | — |
Countries
Netherlands
Outcome results
None listed