Phase 1 Study With Sorafenib and Sirolimus

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00509613
First received: July 30, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Advanced Solid Tumor
Refractory to Standard Therapies
Drug: Sorafenib
Drug: Sirolimus
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Phase 1 Dose Escalation Study With Sorafenib in Combination With Sirolimus in Patients With Solid Tumor

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Secondary Outcome Measures:
  • 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)

Study Start Date: June 2007
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509613

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

No publications provided

Responsible Party: C.M.L. van Herpen, University Medical Centre Nijmegen, st Radboud
ClinicalTrials.gov Identifier: NCT00509613     History of Changes
Other Study ID Numbers: UMCNONCO 2006_01, 2006-006454-10
Study First Received: July 30, 2007
Last Updated: September 17, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on April 17, 2014