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Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00562913
First received: November 21, 2007
Last updated: July 7, 2010
Last verified: July 2010
History of Changes
  Purpose

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
Cancer
 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562913

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00562913     History of Changes
Other Study ID Numbers: 12347
Study First Received: November 21, 2007
Last Updated: July 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by Bayer:
Cancer
Sorafenib
Cyclophosphamide
Doxorubicin

Additional relevant MeSH terms:
Cyclophosphamide
Sorafenib
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
 Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013