Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

NCT00243503 | Completed Phase 2 Results

• 1 other identifier: A6181067
• Study Type: interventional
• Target: 60
• Locations: 5 countries
• Sites: 27

Brief Summary

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Conditions

Breast Neoplasms

Keywords

Breast Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Confirmed Objective Disease Response

  Objective disease response =participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target and non-target lesions. A PR was defined as a \> = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions associated to a non-progressive disease response for the non target lesions.

  From start of treatment through 18 months

Secondary Outcomes (11)

• Duration of Response (DR)

  From start of treatment through 18 months

• Percentage of Participants With Clinical Benefit

  From start of treatment through 18 months

• Progression Free Survival (PFS)

  From start of treatment through 18 months

• Time to Progression (TTP)

  From start of treatment through 18 months

• Overall Survival (OS)

  From start of study treatment until death or 2 years from first study treatment

Study Arms (1)

A

EXPERIMENTAL

Drug: SU011248/Trastuzumab

Interventions

SU011248/Trastuzumab DRUG

SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
• HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
• Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

You may not qualify if:

• Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
• Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
• Prior treatment on a SU11248 clinical trial.
• Uncontrolled brain metastases.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (27)

Pfizer Investigational Site

Montgomery, Alabama, 36106, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19718-6001, United States

Location

Pfizer Investigational Site

Wilmington, Delaware, 19899, United States

Location

Pfizer Investigational Site

Fort Lauderdale, Florida, 33308, United States

Location

Pfizer Investigational Site

Harvey, Illinois, 60426, United States

Location

Pfizer Investigational Site

Tinley Park, Illinois, 60477, United States

Location

Pfizer Investigational Site

Munster, Indiana, 46321, United States

Location

Pfizer Investigational Site

Lafayette, Louisiana, 70503, United States

Location

Pfizer Investigational Site

New Iberia, Louisiana, 70563, United States

Location

Pfizer Investigational Site

Corinth, Mississippi, 38834, United States

Location

Pfizer Investigational Site

Southaven, Mississippi, 38671, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89135, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38104, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Ottignies, 1340, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

Pfizer Investigational Site

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Lyon, 69373, France

Location

Pfizer Investigational Site

Saint-Cloud, 92210, France

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08003, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28040, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

• Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.

  PMID: 24606768 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2005
• First Posted: October 24, 2005
• Study Start: February 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2010
• Last Updated: July 22, 2011
• Results First Posted: May 19, 2010

Record last verified: 2011-07

Locations

ES (3); BE (2); CA (3); FR (3); US (16)