Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	University of Wisconsin, Madison Bayer
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00954278

Purpose

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 twice daily or 800 mg twice daily. Safety and tolerability of sorafenib will also be examined.

Condition	Intervention	Phase
Carcinoma, Non Small Cell Lung	Drug: sorafenib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I, Intrapatient Dose-Escalation Study of Sorafenib in Advanced or Relapsed Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Toleration of dose escalation (dose-limiting toxicities) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of sorafenib in dose-escalation (adverse events and serious adverse events) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sorafenib: Experimental	Drug: sorafenib sorafenib (400mg or 600mg or 800mg) by mouth twice daily, for 28 days

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 mechanisms of action is needed to improve duration and quality of life for NSCLC patients. Sorafenib is an oral-multi-kinase inhibitor with effects on tumor proliferation and tumor angiogenesis.

Sorafenib has demonstrated activity in preclinical models of NSCLC both in combination with chemotherapy and as monotherapy. A recent intra-patient dose escalation trial of sorafenib in renal cell carcinoma showed positive response rates and tolerability up to 1200mg in 91% of patients. This study attempts a similar dose-escalation of sorafenib in NSCLC patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed, advanced (stage IIIB with pleural effusion, stage IV, or recurrent) non-small cell lung cancer (NSCLC)
Measurable disease per RECIST criteria
Patients must have received two 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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954278

Contacts

Contact: Cancer Connect

800-622-8922

uwccc@uwccc.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin - Madison	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect 800-622-8922 uwccc@uwccc.wisc.edu
Sub-Investigator: Tien Hoang, M.D.
Sub-Investigator: Toby Campbell, M.D.

Sponsors and Collaborators

University of Wisconsin, Madison

Bayer

Investigators

Principal Investigator:

Anne M Traynor, M.D.

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin, Madison ( Anne Traynor, M.D. )
Study ID Numbers:	H-2009-0011, CO 08511, IST 000381
Study First Received:	July 30, 2009
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00954278 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

non small cell lung cancer
phase 1
sorafenib
intrapatient dose escalation

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer

Protein Kinase Inhibitors
Sorafenib
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009