Phase 1 Study With Sorafenib and Sirolimus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00509613
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : September 18, 2009
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Refractory to Standard Therapies Drug: Sorafenib Drug: Sirolimus Phase 1

Study Type : Interventional  (Clinical Trial)
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor
Study Start Date : June 2007
Actual Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. identify the recommended doses for the combination of sorafenib and sirolimus for subsequent phase II studies

Secondary Outcome Measures :
  1. to determine the safety profile of the combination therapy of sorafenib with sirolimus
  2. to determine, if possible, the Maximum Tolerated Dose (MTD) of sorafenib and sirolimus in combination therapy
  3. to analyze pharmacokinetic PK profiles (AUC, Cmax) during combination therapy for sorafenib and sirolimus
  4. to evaluate efficacy of the combination descriptively (response rate and rate of stable diseases)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00509613

UMC St Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Principal Investigator: C.M.L. van Herpen, MD, PhD UMC St Radboud

Responsible Party: C.M.L. van Herpen, University Medical Centre Nijmegen, st Radboud Identifier: NCT00509613     History of Changes
Other Study ID Numbers: UMCNONCO 2006_01
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs