NCT00954278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2015

Completed
Last Updated

November 15, 2019

Status Verified

March 1, 2019

Enrollment Period

6.4 years

First QC Date

July 30, 2009

Last Update Submit

November 13, 2019

Conditions

Carcinoma, Non Small Cell Lung

Keywords

non small cell lung cancerphase 1sorafenibintrapatient dose escalation

Outcome Measures

Primary Outcomes (1)

  • Toleration of dose escalation (dose-limiting toxicities)

    One year

Secondary Outcomes (1)

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

    One year

Study Arms (1)

sorafenib

EXPERIMENTAL
Drug: sorafenib

Interventions

sorafenibDRUG

sorafenib (400mg or 600mg or 800mg) by mouth twice daily, for 28 days

Also known as: BAY-439006, Nexavar
sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Anne M Traynor, M.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

August 7, 2009

Study Start

July 28, 2009

Primary Completion

December 23, 2015

Study Completion

December 23, 2015

Last Updated

November 15, 2019

Record last verified: 2019-03

Locations

US(1)