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Sorafenib/Docetaxel Dose Escalation Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Sorafenib/Docetaxel Dose Escalation Trial

A Phase I Dose Escalation Study With Sorafenib Administered Continuously in Combination With Docetaxel Administered Once Every Three Weeks in Patients With Advanced Solid Tumors.

NCT00562523•Bayer

View on ClinicalTrials.gov

Summary

The purpose of this study is to: 1.) Evaluate how your body reacts to sorafenib when taken daily (continuously) in combination with docetaxel given every 3 weeks, and to determine the safety of the two drugs together.2.) Measure your blood levels of sorafenib and docetaxel at specific times after taking the medications.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age greater than or equal to 18 years
•Advanced histological or cytological documentation of cancer
•At least one evaluable lesion
•ECOG Performance Status of 0 or 1
•No more than one prior chemotherapy regimen (prior adjuvant therapy, immunotherapy or hormone treatment are allowed and not restricted)
•Life expectancy of at least 12 weeks
•No previous exposure to docetaxel or sorafenib
•Adequate bone marrow, liver and renal function as assessed by the following:
•* Hemoglobin greater than or equal to 9.0 g/dL
•* Absolute neutrophil count (ANC) greater than or equal to 2,500/mm3
+5 more criteria

Exclusion Criteria

•Myocardial infarction or symptomatic coronary artery disease (severe or unstable angina) within 6 months prior to screening
•Active clinically serious infections (\> Grade 2 NCI-CTCAE Version 3.0)
•Uncontrolled seizure disorder. Use of cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital) is not allowed
•Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
•Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
•Peripheral neuropathy \> Grade 1
•Thrombotic or embolic events (such as transient ischemic attacks, myocardial infarction, pulmonary embolus), within 6 months prior to screening
•Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study treatment
•Pregnant or breast feeding women

Locations (2)

Tampa, Florida, United States

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

March 1, 2009

Completion Date

March 1, 2009

Last Updated

May 23, 2013

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

Sorafenib (Nexavar, BAY43-9006)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sorafenib/Docetaxel Dose Escalation Trial

Inclusion Criteria

Exclusion Criteria

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