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

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedsorafenib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 15, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Wisconsin, Madison

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: University of Wisconsin, Madison
Interventions being studied: Drug: sorafenib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Wisconsin - MadisonMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 15, 2019. Always confirm current availability with the study team.

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