Trial Condition(s):
Cancer
Phase I Study of sorafenib dosed continuously with Cyclophosphamide and Doxorubicin
Bayer Identifier:
12347
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Cross Cancer Institute Edmonton, Canada, T6G 1Z2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administeredTimeframe: 6 weeks
Secondary Outcome
- To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenibTimeframe: 6 weeks
Additional Information
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