Phase 1 Study With Sorafenib and Sirolimus

Phase 1

Completed

• Conditions: Advanced Solid Tumor; Refractory to Standard Therapies

• Registration Number: NCT00509613
• Lead Sponsor: Radboud University Medical Center

Brief Summary

The purpose of the trial is to identify the recommended dose of sorafenib and sirolimus for combination therapy in subsequent phase 2 trials.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-07-30
• Study First Submitted QC: 2007-07-30
• Study First Posted: 2007-07-31
• Primary Completion: 2009-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies

Secondary Outcome Measures

Name	Time	Method
to determine the safety profile of the combination therapy of sorafenib with sirolimus
to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)

Trial Locations

Locations (1)

UMC St Radboud; 🇳🇱 Nijmegen, Netherlands