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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562523

Enrollment

Registered

2007-11-22

Start date

2007-11-30

Completion date

2009-03-31

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer, Docetaxel, Sorafenib

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.

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 * 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

Design outcomes

Primary

Measure	Time frame
To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib	6 weeks

Secondary

Measure	Time frame
To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026