Trial Condition(s):

Cancer

Phase I Study of sorafenib dosed continuously with Cyclophosphamide and Doxorubicin

Bayer Identifier:

12347

ClinicalTrials.gov Identifier:

NCT00562913

EudraCT Number:

Not Available

Study Completed

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

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

Trial Summary

Enrollment Goal
21
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 

Trial Design