Phase 1 Study With Sorafenib and Sirolimus

Advanced Solid Tumor Clinical Trial

Official title:

Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509613
• Other study ID #: UMCNONCO 2006_01
• Secondary ID: 2006-006454-10
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2007
• Last updated: September 17, 2009
• Start date: June 2007

Study information

• Verified date: September 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Refractory to Standard Therapies

Intervention

Drug:
• Sorafenib

• Sirolimus

Locations

Country	Name	City	State
Netherlands	UMC St Radboud	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies
Secondary	to determine the safety profile of the combination therapy of sorafenib with sirolimus
Secondary	to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
Secondary	to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
Secondary	to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)