Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: November 21, 2007
Last updated: November 24, 2013
Last verified: November 2013
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 Intervention Phase
Drug: Nexavar (Sorafenib, BAY43-9006)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 identifier: NCT00562913

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

Additional Information:
Responsible Party: Bayer Identifier: NCT00562913     History of Changes
Other Study ID Numbers: 12347 
Study First Received: November 21, 2007
Last Updated: November 24, 2013
Health Authority: Canada: Health Canada

Keywords provided by Bayer:

Additional relevant MeSH terms:
Liposomal doxorubicin
Alkylating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Physiological Effects of Drugs
Protein Kinase Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on May 26, 2016