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Sorafenib/Docetaxel Dose Escalation Trial

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00562523
First received: November 21, 2007
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Neoplasms
 Drug: Nexavar (Sorafenib, BAY43-9006)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: November 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Nexavar (Sorafenib, BAY43-9006)
Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562523

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00562523     History of Changes
Other Study ID Numbers: 12438
Study First Received: November 21, 2007
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Cancer
Docetaxel
Sorafenib

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Sorafenib
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013