Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562913

Enrollment

Registered

2007-11-26

Start date

2007-12-31

Completion date

2010-03-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Sorafenib, Cyclophosphamide, Doxorubicin

Brief summary

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

Interventions

DRUGNexavar (Sorafenib, BAY43-9006)

Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered	6 weeks

Secondary

Measure	Time frame
To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib	6 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026