NCT00562523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

November 21, 2007

Last Update Submit

May 22, 2013

Conditions

Neoplasms

Keywords

CancerDocetaxelSorafenib

Outcome Measures

Primary Outcomes (1)

  • To determine the safety, maximum tolerated dose and dose-limiting toxicities of oral sorafenib

    6 weeks

Secondary Outcomes (1)

  • To determine if there is a pharmacokinetic interaction between sorafenib and docetaxel when they are administered together

    6 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

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

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 22, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

US(2)