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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 weeks

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

12438

NCT ID:

NCT00562523

Start Date:

November 2007

Completion Date:

March 2009

Related Keywords:

  • Neoplasms
  • Cancer
  • Docetaxel
  • Sorafenib
  • Neoplasms

Name

Location

Miami, Florida  33176
Philadelphia, Pennsylvania  19104