search
Back to results

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

Primary Purpose

Carcinoma, Non Small Cell Lung

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sorafenib
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non Small Cell Lung focused on measuring non small cell lung cancer, phase 1, sorafenib, intrapatient dose escalation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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

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

Sites / Locations

  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Toleration of dose escalation (dose-limiting toxicities)

Secondary Outcome Measures

Safety of sorafenib in dose-escalation (adverse events and serious adverse events)

Full Information

First Posted
July 30, 2009
Last Updated
November 13, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00954278
Brief Title
Intra-patient Dose Escalation Study of Sorafenib in Advanced Non-small Cell Lung Cancer
Official Title
A Phase I, Intrapatient Dose-Escalation Study of Sorafenib in Advanced or Relapsed Non-Small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2009 (Actual)
Primary Completion Date
December 23, 2015 (Actual)
Study Completion Date
December 23, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non Small Cell Lung
Keywords
non small cell lung cancer, phase 1, sorafenib, intrapatient dose escalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sorafenib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sorafenib
Other Intervention Name(s)
BAY-439006, Nexavar
Intervention Description
sorafenib (400mg or 600mg or 800mg) by mouth twice daily, for 28 days
Primary Outcome Measure Information:
Title
Toleration of dose escalation (dose-limiting toxicities)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Safety of sorafenib in dose-escalation (adverse events and serious adverse events)
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Traynor, M.D.
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs