Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nexavar (Sorafenib, BAY43-9006)

Drug

Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Primary outcomes

To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered

Time frame: 6 weeks

Secondary outcomes

To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2010
First posted: Nov 26, 2007
Registry last updated: Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed