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Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin

NCT ID: NCT00562913

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Cancer

Keywords

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Cancer Sorafenib Cyclophosphamide Doxorubicin

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Nexavar (Sorafenib, BAY43-9006)

Intervention Type DRUG

Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Interventions

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Nexavar (Sorafenib, BAY43-9006)

Cyclophosphamide plus 400 mg BID sorafenib and doxorubicin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Edmonton, Alberta, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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12347

Identifier Type: -

Identifier Source: org_study_id