Study Of Sunitinib With Capecitabine In Breast Cancer
A Phase II Study Of Sunitinib Malate In Combination With Capecitabine In Patients With Advanced Or Metastatic Breast Cancer
1 other identifier
interventional
63
1 country
17
Brief Summary
To evaluate efficacy, safety and pharmacokinetics of sunitinib plus Capecitabine in Japanese patients with advanced/metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Typical duration for phase_2
17 active sites
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
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedResults Posted
Study results publicly available
October 13, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 27, 2013
May 1, 2013
1.7 years
April 17, 2008
September 20, 2010
May 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Objective Response Based on Data Review Committee's Assessment
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST). CR is defined as disappearance of all target and non-target lesions. PR is defined as ≥30% decrease in sum of the longest dimensions (LDs) of the target lesions taking as reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat evaluation ≥4 weeks after initial documentation of response.
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Secondary Outcomes (16)
Number of Participants With Objective Response Based on Investigator's Assessment
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Number of Participants With Clinical Benefit Response (CBR) Based on Data Review Committee's Assessment
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8.
Number of Subjects With CBR Based on Investigator's Assessment
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of study.
Progression-Free Survival (PFS)
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
Time to Tumor Progression (TTP)
Day 1 of Cycle 2, every 6 weeks after Cycle 2, and at the end of Cycle 8. Up to 28 days after the last administration of the study drug.
- +11 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Capecitabine 1000 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Eligibility Criteria
You may qualify if:
- Histologically- or cytologically-proven diagnosis of breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent
- Measurable disease as per RECIST. Measurable lesions that have been previously irradiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
- Prior treatment with an anthracycline and a taxane in the neoadjuvant, adjuvant or metastatic disease settings.
You may not qualify if:
- Histology of inflammatory carcinoma with no other measurable disease. Patients with histology of inflammatory carcinoma are allowed on study if they have measurable disease.
- Brain metastases, spinal cord compression, or carcinomatous meningitis, or leptomeningeal disease.
- Prior treatment with 5-fluorouracil (5-FU) and 5-FU derivatives such as Furtulon (5'-DFUR), Futraful/ Sunfural (tegafur), UFT/UFT-E (tegafur/uracil), TS-1 (tegafur/gimeracil/oteracil) or Mifurol (carmofur) in metastatic disease setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Pfizer Investigational Site
Anjo, Aichi-ken, Japan
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Okazaki, Aichi-ken, Japan
Pfizer Investigational Site
Toyoake, Aichi-ken, Japan
Pfizer Investigational Site
Chiba, Chiba, Japan
Pfizer Investigational Site
Matsuyama, Ehime, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Morioka, Iwate, Japan
Pfizer Investigational Site
Kyoto, Japan, Japan
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Osaka, Osaka, Japan
Pfizer Investigational Site
Sakai, Osaka, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Niigata, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 21, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2009
Study Completion
May 1, 2012
Last Updated
May 27, 2013
Results First Posted
October 13, 2010
Record last verified: 2013-05