Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
- 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).
- Men or women of at least 18 years
- Patients who have an ECOG status of 0 or 1
- Patients who have a life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function
- Negative pregnancy test for female patients of childbearing potential
- Women and men enrolled into this trial must use adequate birth control measures
during the course of the trial.
- Signed informed consent
- History of serious cardiac disease
- Active clinically serious bacterial, viral or fungal infections (> grade 2).
- Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B
- Clinically symptomatic brain or meningeal metastasis.
- Patients with seizure disorders requiring medication (such as steroids or
- Patients with evidence or history of bleeding diathesis.
- Substance abuse, medical, psychological or social conditions that may interfere with
the patients participation in the study or evaluation of the study results.
- Concomitant treatment with strong CYP3A4 inductors (such as rifampicin, St. John´s
Wort) or CYP3A4 inhibitors (such as ketoconazole, voriconazole, itraconazole,
diltiazem, verapamil, erythromycin). Moderate or weak CYP3A4 modifiers should be used
concomitantly only after careful assessment of risk-benefit ratio. Concomitant use of
carbamazepine, phenobarbital, phenytoin or chronic use of dexamethasone is excluded