Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

NCT00319254 | Completed Phase 2 Results

• 2 other identifiers: 3160A2-201B1871014
• Study Type: interventional
• Target: 75
• Locations: 8 countries
• Sites: 15

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.

Conditions

Breast Neoplasms; Neoplasm Metastasis

Keywords

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS) Rate

  PFS was based on Kaplan-Meier estimates. PFS was defined as time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from death case report forms (CRFs). Percentage of participants who had not experienced progression or death by Week 16 is reported.

  Baseline up to Week 16

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.

  Baseline up to 30 days after last dose of study treatment

Secondary Outcomes (8)

• Overall Survival (OS)

  Baseline up to Year 2

• Percentage of Participants With Objective Response (OR)

  Baseline up to Year 1

• Percentage of Participants With Clinical Benefit

  Baseline up to end of treatment (Week 77)

• Number of Participants With Change From Baseline in Laboratory Test Results

  Baseline up to end of treatment (Week 77)

• Number of Participants With Change From Baseline in Electrocardiogram (ECG)

  Baseline up to end of treatment (Week 77)

Other Outcomes (1)

• Population Pharmacokinetics (PK)

  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

Study Arms (1)

Advanced breast cancer

EXPERIMENTAL

Drug: SKI-606 (Bosutinib)

Interventions

SKI-606 (Bosutinib) DRUG

SKI-606 (Bosutinib) 400mg once daily, for as long as tolerated or until disease progression.

Advanced breast cancer

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Pfizer Investigational Site

Duarte, California, 91010-3000, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33612, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

Pfizer Investigational Site

Dijon, 21034, France

Location

Pfizer Investigational Site

Saint-Herblain, 44805, France

Location

Pfizer Investigational Site

Pokfulam, Hong Kong

Location

Pfizer Investigational Site

Floriana, VLT 14, Malta

Location

Pfizer Investigational Site

Lodz, 90-553, Poland

Location

Pfizer Investigational Site

Wroclaw, 51-124, Poland

Location

Pfizer Investigational Site

Moscow, 115478, Russia

Location

Pfizer Investigational Site

Sumy, Ukraine, 40005, Ukraine

Location

Pfizer Investigational Site

Dnipropetrovsk, 49102, Ukraine

Location

Pfizer Investigational Site

Uzhhorod, 88014, Ukraine

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 27, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 31, 2013
• Results First Posted: January 31, 2013

Record last verified: 2012-12

Locations

PL (2); AU (1); FR (2); UA (3); US (4); MA (1); RU (1); HK (1)