NCT00661180

Brief Summary

The purpose of this study is to evaluate the anti-cancer activity and safety of Bay 43-006, in patients who have Chronic Myelogenous Leukemia that resisted to Gleevec treatment, one of the standard medication administered for these patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_2

Geographic Reach
2 countries

4 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

January 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

April 15, 2008

Last Update Submit

December 18, 2014

Conditions

Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

  • To determine the major hematologic response rate (i.e. complete and partial hematologic responses) associated with BAY 43-9006 in patients with chronic phase CML resistant to Gleevec.

    Every 3 months

Secondary Outcomes (7)

  • To determine the cytogenetic response rate associated with BAY 43-9006.

    Every 3 months

  • To evaluate the duration of hematologic response to BAY 43-9006.

    Throughout study until end of response

  • To evaluate the duration of cytogenetic response to BAY 43-9006.

    Throughout study until end of response

  • To assess time to progression.

    Until event occurs

  • To assess overall survival..

    During Follow up

  • +2 more secondary outcomes

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Nexavar (Sorafenib, BAY43-9006)

Interventions

Nexavar (Sorafenib, BAY43-9006)DRUG

Patients will receive Bay 43-9006 400 mg po twice daily in a continuous, uninterrupted schedule. Treatment will continue until there is objective evidence of disease progression, or until evidence of toxicities that are unacceptable and thought to be related to study drug, which requires discontinuation of drug, or due to withdrawn patient consent.

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 (4)

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Lyon, 69437, France

Location

Unknown Facility

Paris, 75010, France

Location

Unknown Facility

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic 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
Expanded Access
Yes

Study Record Dates

First Submitted

April 15, 2008

First Posted

April 18, 2008

Study Start

January 1, 2004

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(1)FR(3)