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
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancer
Both
Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Canada: Health Canada
Study ID:
12347
NCT ID:
NCT00562913
Start Date:
December 2007
Completion Date:
March 2010
Related Keywords:
- Cancer
- Cancer
- Sorafenib
- Cyclophosphamide
- Doxorubicin
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