Sorafenib/Docetaxel Dose Escalation Trial

Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562523
• Other study ID #: 12438
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2007
• Last updated: May 22, 2013
• Start date: November 2007
• Est. completion date: March 2009

Study information

• Verified date: May 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Onyx Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib		6 weeks	Yes
Secondary	To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together		6 weeks	Yes

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