NCT00657254

Brief Summary

The study was designed to allow for the continuation of treatment with Sorafenib as a single agent to those patients who participated in a previous Sorafenib study that had reached its designated end-date and who were, in the opinion of the Investigator and the Sponsor, still benefiting from treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2002

Geographic Reach
4 countries

6 active sites

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

December 1, 2002

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

April 8, 2008

Last Update Submit

December 18, 2014

Conditions

NeoplasmMetastasis

Keywords

ExtensionSorafenibSurvival

Outcome Measures

Primary Outcomes (1)

  • Survival

    Death

Secondary Outcomes (5)

  • Objective Tumour Response Rate

    Number of confirmed partial and complete responses

  • Overall Response Duration

    Time from the date of the first intake of sorafenib to the date that progressive disease is documented.

  • Time to Objective Response

    Time from the date of the first intake of sorafenib to the date that objective response is first documented.

  • Time to Disease Progression

    Time from first intake of sorafenib to disease progression

  • Safety Parameters

    Throughout study

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Nexavar (Sorafenib, BAY43-9006)

Interventions

Nexavar (Sorafenib, BAY43-9006)DRUG

Bay 43-9006 400mg (2 x 200mg tablets) orally twice daily until withdrawal.

Arm 1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Boston, Massachusetts, 02115-6084, United States

Location

Unknown Facility

Bruxelles - Brussel, 1000, Belgium

Location

Unknown Facility

Hamilton, Ontario, L8V 5C2, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Essen, North Rhine-Westphalia, 45147, Germany

Location

Unknown Facility

Herne, North Rhine-Westphalia, 44625, Germany

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

December 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

CA(2)US(1)DE(2)BE(1)