check_circleStudy Completed

Neoplasms

Bayer Identifier:

12438

ClinicalTrials.gov Identifier:

NCT00562523

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sorafenib/Docetaxel Dose Escalation Trial

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
17
Trial Dates
November 2007 - March 2009
Phase
Phase 1
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
H. Lee Moffitt Cancer Center & Research InstituteTampa, 33612, United States
Completed
Fox Chase Cancer CenterPhiladelphia, 19111-2497, United States

Primary Outcome

  • To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.