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Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

Phase II Study Of SKI-606 In Subjects With Advanced Or Metastatic Breast Cancer


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival (PFS) Rate

Outcome Description:

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.

Outcome Time Frame:

Baseline up to Week 16

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A2-201

NCT ID:

NCT00319254

Start Date:

May 2006

Completion Date:

February 2009

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Advanced Breast Cancer
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteClearwater, Florida  33761