Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562913
• Other study ID #: 12347
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: November 24, 2013
• Start date: December 2007
• Est. completion date: March 2010

Study information

• Verified date: November 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Nexavar (Sorafenib, BAY43-9006)
Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered		6 weeks	Yes
Secondary	To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib		6 weeks	No

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