Phase 1 Study With Sorafenib and Sirolimus

NCT ID: NCT00509613

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30

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.

Conditions

Advanced Solid Tumor; Refractory to Standard Therapies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Sorafenib

Intervention Type: DRUG

Sirolimus

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

University Medical Centre Nijmegen, st Radboud

Principal Investigators

C.M.L. van Herpen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC St Radboud

Locations

UMC St Radboud

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

2006-006454-10

Identifier Type: -

Identifier Source: secondary_id

UMCNONCO 2006_01

Identifier Type: -

Identifier Source: org_study_id