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Sorafenib/Docetaxel Dose Escalation Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00562523
Recruitment Status : Completed
First Posted : November 22, 2007
Last Update Posted : May 23, 2013
Sponsor:
Collaborator:
Amgen
Information provided by:
Bayer

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Sorafenib (Nexavar, BAY43-9006) Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2007
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks



Primary Outcome Measures :
  1. To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
    • Platelet count greater than or equal to 100,000/mm3 Hepatic
    • Total Bilirubin less than or equal to ULN
    • AST, ALT and Alkaline Phosphatase less than 1.5x ULN.
    • PT-INR/PTT less than 1.5 x ULN (Patients who are being prophylactically anti coagulated with an agent such as coumadin or heparin will be allowed to participate provided that the INR less than 1.5. In addition, these patients must be monitored at appropriate intervals throughout study)
    • Serum creatinine less than or equal to 1.5 x upper limit of normal

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562523


Locations
United States, Florida
Tampa, Florida, United States, 33612
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Bayer
Amgen
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Head Clinical Pharmacology, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00562523     History of Changes
Other Study ID Numbers: 12438
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Bayer:
Cancer
Docetaxel
Sorafenib

Additional relevant MeSH terms:
Docetaxel
Sorafenib
Niacinamide
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs