Study Evaluating SKI-606 in Subjects With Breast Cancer - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00319254

Purpose

The purpose of this study is to determine if SKI-606 is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.

Condition	Intervention	Phase
Breast Neoplasms Neoplasm Metastasis	Drug: SKI-606	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of SKI-606 in Subjects With Advanced or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Bosutinib

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Determine the rate of progression free survival (PFS) at 16 weeks. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the safety profile of 400mg/day [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Determine the rate of objective response within 1 year and the survival rate at 3 years after beginning SKI-606 treatment [ Time Frame: 1 year and 3 years ] [ Designated as safety issue: No ]
Determine the pharmacokinetics (PK) of SKI-606 in this patient population. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	April 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

400mg, capsule, QD, continuous

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Stage IIIB, IIIC or IV breast cancer not curable with available therapy
Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens
Life expectancy of at least 16 weeks
Ability to swallow whole capsules

Exclusion Criteria:

Use of or requirement for bisphosphonates within 8 weeks prior to screening
Any other cancer within 5 years of screening, except for basal cell carcinoma or cervical carcinoma in situ
Uncontrolled cardiac disease including congestive heart failure, angina, heart attack, etc.
Recent or ongoing significant gastrointestinal disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319254

Locations

United States, California

Santa Monica, California, United States, 90404

Santa Monica, California, United States, 90404

San Francisco, California, United States, 94115-1710
United States, Florida

Tampa, Florida, United States, 33612
United States, Ohio

Cleveland, Ohio, United States, 44195

Duarte, Ohio, United States, 91010-3000
China

Hong Kong, China
France

Toulouse, France, 31052

MONTBELIARD Cedex, France, 25209

SAINT HERBLAIN, France, 44805
Ireland

Dublin 4, Ireland
Italy

Genoa, Italy, 16132

Roma, Italy, 00144
Malta

Floriana, Malta
Poland

Łódź, Poland, 90-553

Wrocław, Poland, 51-124

BYDGOSZCZ, Poland, 85-796
Russian Federation

St. Petersburg, Russian Federation

Moscow, Russian Federation, 115478
Ukraine

Uzhgorod, Ukraine, 88014

Dnepropetrovsk, Ukraine, 49102

Sumy, Ukraine, 40005
United Kingdom

Glasgow, United Kingdom, G31 2ER

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3160A2-201
Study First Received:	April 24, 2006
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00319254 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Ministry of Health; Italy: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Ukraine: Ministry of Health; Poland: Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Hong Kong: Department of Health; Malta: Ministry of Health

Keywords provided by Wyeth:

Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on August 30, 2009