check_circleStudy Completed

Cancer

Bayer Identifier:

12347

ClinicalTrials.gov Identifier:

NCT00562913

EudraCT Number:

Not Available

EU CT Number:

Not Available
Phase I Study of sorafenib dosed continuously with Cyclophosphamide and Doxorubicin

Trial 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

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - > 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

Trial summary

Enrollment Goal
21
Trial Dates
December 2007 - March 2010
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cross Cancer InstituteEdmonton, T6G 1Z2, Canada
Completed
Sir Mortimer B. Davis Jewish General HospitalMontreal, H3T 1E2, Canada

Primary Outcome

  • To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
    date_rangeTime Frame:
    6 weeks
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    Safety Issue:
    yes

Secondary Outcome

  • To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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