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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014