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A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Breast Cancer (Parts 1 and 2), Advanced Pancreatic Cancer (Part 1), Advanced Colorectal Cancer (Part 1), Advanced Cholangiocarcinoma (Part 1), Advanced Glioblastoma Multiforme (Part 1)

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Trial Information

A Phase 1/2, Open-Label Study Of Bosutinib Administered In Combination With Capecitabine In Subjects With Solid Tumor And ErbB2 Negative Locally Advanced Or Metastatic Breast Cancer


The study was prematurely discontinued following Part 1 evaluation, when the sponsor
concluded that further translational biomarker analyses were needed to better define the
breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the
Sponsor made a determination to stop the study after Part 1 as communicated to investigators
on 02Dec2010 . No subjects were enrolled into Part 2 of this study. The study was not
terminated due to safety reasons.


Inclusion Criteria:



Part 1:

- Ages eligible for study: 18 years or older.

- Male and female.

- Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or
colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available
therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.

Part 2:

- Ages eligible for study: 18 years or older.

- Female.

- Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or
loco-regional recurrent breast cancer that is not amenable to curative treatment with
surgery or radiotherapy.

- Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently
analyzed biopsy.

Exclusion Criteria:

Part 1:

- Prior bosutinib, or any other prior Src inhibitor.

- Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease
is allowed unless patient stopped therapy for toxicity.

Part 2:

- Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with
capecitabine or 5-FU for the treatment of metastatic disease.

- Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the
past 12 months.

- erbB2+ breast cancer.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) - Part 1

Outcome Description:

The MTD contour is defined as the dose combinations that achieve a toxicity rate (dose-limiting toxicity [DLT] rate) of less than (<) 1/3. The observed toxicity rates for all the reporting groups (to which at least 1 cohort of participants was allocated) was estimated by calculating the proportion of DLTs observed in the first 21 days of treatment at those reporting groups. DLT includes grade (Gr) 3/4 nausea, vomiting, diarrhea, or asthenia more than 3 days, Gr 4 hematologic toxicities, delayed study treatment administration due to dose toxicities by more than 3 weeks. Pre-defined criterion for MTD: if a higher dose level of capecitabine existed such that the same dose level of bosutinib had a DLT rate of <1/3, no MTD was recommended for that capecitabine dose and if even the lowest dose of bosutinib achieved a toxicity rate of greater than (>) 1/3, no MTD was recommended for that capecitabine dose level.

Outcome Time Frame:

Part 1 Baseline up to Day 21

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A6-2208

NCT ID:

NCT00959946

Start Date:

September 2009

Completion Date:

March 2011

Related Keywords:

  • Advanced Breast Cancer (Parts 1 and 2)
  • Advanced Pancreatic Cancer (Part 1)
  • Advanced Colorectal Cancer (Part 1)
  • Advanced Cholangiocarcinoma (Part 1)
  • Advanced Glioblastoma Multiforme (Part 1)
  • Phase 1/2
  • 2-part study
  • bosutinib and capecitabine
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Glioblastoma
  • Pancreatic Neoplasms
  • Cholangiocarcinoma

Name

Location

Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteNorth Adams, Massachusetts  01247