Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

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: NCT00562913
Recruitment Status : Completed
First Posted : November 26, 2007
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):

Brief Summary:
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients

Condition or disease Intervention/treatment Phase
Cancer Drug: Nexavar (Sorafenib, BAY43-9006) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors
Study Start Date : December 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Primary Outcome Measures :
  1. To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib [ Time Frame: 6 weeks ]

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:

  • At least 18 years old
  • Advanced histological or cytological documentation of cancer
  • life-expectancy of at least 12 weeks
  • able to swallow pills
  • ECOG status of 0,1 or 2
  • adequate bone marrow
  • liver and renal function

Exclusion Criteria:

  • > NYHA Class 2 CHF
  • Serious myocardial dysfunction,
  • or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed)
  • History of organ allograft
  • uncontrolled hypertension
  • renal dialysis
  • Bleeding event/hemorrhage within 4 weeks of study treatment
  • major surgery within 4 weeks of study treatment
  • Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose

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): NCT00562913

Canada, Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00562913     History of Changes
Other Study ID Numbers: 12347
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013

Keywords provided by Bayer:

Additional relevant MeSH terms:
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors
Vitamin B Complex
Growth Substances