Sorafenib/Docetaxel Dose Escalation Trial

NCT ID: NCT00562523

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-03-31

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Sorafenib (Nexavar, BAY43-9006)

Intervention Type: DRUG

Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks

Interventions

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400mg by mouth daily in combination with docetaxel 60mg/m2 IV once every 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer HealthCare Pharmaceuticals Inc.

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Tampa, Florida, United States

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

12438

Identifier Type: -

Identifier Source: org_study_id