Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

November 24, 2013 updated by: Bayer

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 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 22, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 24, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12347

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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