Sorafenib and Sirolimus in Advanced Solid Tumor and Refractory to Standard Therapies - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Nijmegen, Netherlands
    - UMC St Radboud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Bayer

Investigators

Principal Investigator: C.M.L. van Herpen, MD, PhD, UMC St Radboud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 30, 2007

First Submitted That Met QC Criteria