Status:
COMPLETED
Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Bayer
Conditions:
Carcinoma, Non Small Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the number of patients with advanced, relapsed non-small cell lung cancer who can tolerate dose escalation sorafenib from 400 mg twice daily to either 600 mg ...
Detailed Description
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality in the U.S. Time to progression in advanced disease remains poor and further study of newer agents with novel mechan...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, advanced (stage IIIB with pleural effusion, stage IV, or recurrent), kras mutation positive, non-small cell lung cancer (NSCLC)
- Measurable disease per RECIST criteria
- Patients must have received one + prior chemotherapy regimens for NSCLC
- Patients may have treated and clinically stable brain metastases
- Adequate bone marrow, liver and renal function
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation, and for 3 months after last administration of sorafenib
- Patients must have the ability to understand and willingness to sign a written informed consent
- International normalized ratio(INR) \< 1.5 or prothrombin time/ partial thromboplastin time (PT/PTT) within normal limits
Exclusion
- Prior exposure to a Ras pathway inhibitor
- Any other anti-tumor therapy within 3 weeks of enrollment
- Prior bevacizumab within the past 6 weeks
- An active secondary malignancy except non-melanoma skin cancer
- Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Uncontrolled hypertension, defined as systolic blood pressure \> 150mm Hg or diastolic pressure \> 90mm Hg, despite optical medical management
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C
- Active clinically serious infection \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attack within the past 6 months
- Pulmonary hemorrhage/bleeding event \>/= CTCAE Grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event \>/= CTCAE Grade 3 within 4 weeks of first dose of study drug
- Serious non-healing wound, ulcer, or bone fracture
- Evidence or history of bleeding diathesis or coagulopathy
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug
- Use of St. John's Wort or rifampin
- Known or suspected allergy to sorafenib or any agent given in the course of the trial
- Any condition that impairs patient's ability to swallow whole pills
- Any malabsorption problem
Key Trial Info
Start Date :
July 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2015
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00954278
Start Date
July 28 2009
End Date
December 23 2015
Last Update
November 15 2019
Active Locations (1)
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1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792