Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00562913
• Collaborator: (none)
• Enrollment: 21
• Locations: 2
• Arm: 1
• Duration (Months): 27
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Nexavar (Sorafenib, BAY43-9006)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Nexavar (Sorafenib, BAY43-9006); Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Outcome Measures

Primary Outcome Measures

1. To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered [6 weeks]

Secondary Outcome Measures

1. To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Edmonton	Alberta	Canada	T6G 1Z2
2		Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00562913
• Other Study ID Numbers: 12347
• First Posted: Nov 26, 2007
• Last Update Posted: Nov 26, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by Bayer: Cancer; Sorafenib; Cyclophosphamide; Doxorubicin
• Additional relevant MeSH terms: Sorafenib

Study Results

No Results Posted as of Nov 26, 2013