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Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Locally Advanced or Metastatic Breast Cancer

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Trial Information

Parallel Phase I Study of Ixabepilone Plus Lapatinib and Ixabepilone Plus Lapatinib Plus Capecitabine in Subjects With HER2 Positive Locally Advanced or Metastatic Breast Cancer


Inclusion Criteria:



- Females aged 18 years or older with histologic or cytologic diagnosis of
adenocarcinoma originating in the breast

- Radiologic or pathologic evidence that the cancer is metastatic or locally advanced
(a T4 tumor and stage IIIB/IIIC disease) and not curable by local measures, such as
radiation or surgery

- Positive status for human epidermal growth factor receptor 2

- Measurable disease as per Response Evaluation Criteria In Solid Tumors guidelines

- Karnofsky performance status of 70 to 100

- Life expectancy of at least 3 months

Exclusion Criteria:

- Prior radiation must not have included 30% or more of major bone-marrow containing
areas, such as the pelvis and lumbar spine

- Common Terminology Criteria Grade 2 or greater neuropathy

- Inadequate hematologic, hepatic, or renal function

- Known prior severe hypersensitivity reactions to agents containing Cremophor® EL or
known hypersensitivity or prior intolerance to fluoropyrimidine

- Known or suspected dihydropyrimidine dehydrogenase deficiency

- More than 3 prior chemotherapy regimens in the metastatic setting

- Prior treatment with an epothilone or lapatinib; prior treatment with capecitabine
within the past 6 months

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib

Outcome Description:

The MTD is defined as the maximum dose that can be administered to 6 participants such that no more than 1 (or fewer than one third if more than 6 participants receive treatment) experiences a dose-limiting toxicity (DLT), with at least 2 experiencing a DLT at the next higher dose level. The RP2D is based on the MTD and the assessment of any relevant chronic toxicities.

Outcome Time Frame:

Days 1 through 21

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA163-144

NCT ID:

NCT00634088

Start Date:

June 2008

Completion Date:

June 2010

Related Keywords:

  • Locally Advanced or Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

The Cancer Institute of New Jersey New Brunswick, New Jersey  08901