Clinical trial · Interventional
Phase 1 Study With Sorafenib and Sirolimus
Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
NCT00509613CI-TRIAL-00002648completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Refractory to Standard Therapies | — | UNRESOLVED | — |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies
Secondary outcomes (4)
- measure
- to determine the safety profile of the combination therapy of sorafenib with sirolimus
- measure
- to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
- measure
- to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
- measure
- to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 or C. * Clinically symptomatic brain or meningeal metastasis. * Patients with seizure disorders requiring medication (such as steroids or antiepileptics). * 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
References
Publications (0)
Data not yet available
No reference posted for this study.