Clinical trial NCT00319254: Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer
Official title: Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: Advanced Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if SKI-606 (Bosutinib) 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.


Eligibility 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

Primary outcomes:
measure: Progression-Free Survival (PFS) Rate
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after last dose of study treatment
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline up to Year 2
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline up to Year 1
measure: Percentage of Participants With Clinical Benefit
timeFrame: Baseline up to end of treatment (Week 77)
measure: Number of Participants With Change From Baseline in Laboratory Test Results
timeFrame: Baseline up to end of treatment (Week 77)
measure: Number of Participants With Change From Baseline in Electrocardiogram (ECG)
timeFrame: Baseline up to end of treatment (Week 77)
measure: Number of Participants With Change From Baseline in Vital Signs, Physical Examinations, and Ophthalmological Examinations
timeFrame: Baseline up to end of treatment (Week 77)
measure: Concomitant Medications Used for Management of Adverse Events (AEs)
timeFrame: Day 1 up to end of treatment (Week 77)
measure: Change From Baseline in Karnofsky Performance Status (KPS) at Week 1, 4, 8, 12, 16, Every 8 Weeks Thereafter and 14 Days After Last Dose of Study Treatment
timeFrame: Baseline, Weeks 1,4,8,12,16, every 8 weeks thereafter and 14 days after last dose of study treatment
Other outcomes:
measure: Population Pharmacokinetics (PK)
timeFrame: Pre-dose, 2, 7, 20 hours post-dose on Day 1 of Week 4 and pre-dose on Day 1 of Weeks 1, 8, 12, 16, and 24
Locations:
city: Duarte
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Saint-Herblain
country: France
facility: Pfizer Investigational Site
city: Pokfulam
country: Hong Kong
facility: Pfizer Investigational Site
city: Floriana
country: Malta
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Sumy
country: Ukraine
facility: Pfizer Investigational Site
city: Uzhgorod
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: