Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

NCT ID: NCT00634088

Last Updated: 2016-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.

Conditions

Locally Advanced or Metastatic Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

Dose Level 1

Group Type: EXPERIMENTAL

Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

Intervention Type: DRUG

Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle.

Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Dose Level 2

Group Type: EXPERIMENTAL

Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Intervention Type: DRUG

Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle.

Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

Dose Level 3

Group Type: EXPERIMENTAL

Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

Intervention Type: DRUG

Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle.

Ixabepilone + Lapatinib + Capecitabine

Triplet Combination

Group Type: EXPERIMENTAL

Ixabepilone + Lapatinib + Capecitabine

Intervention Type: DRUG

Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.

Interventions

Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg

Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle.

Intervention Type: DRUG

Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg

Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle.

Intervention Type: DRUG

Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg

Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle.

Intervention Type: DRUG

Ixabepilone + Lapatinib + Capecitabine

Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

R-Pharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

The Cancer Institute Of New Jersey

New Brunswick, New Jersey, United States

Local Institution

Brisbane, Queensland, Australia

Local Institution

Modena, , Italy

Countries

United States; Australia; Italy

Related Links

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

EURDRACT: 2007-004123-38

Identifier Type: -

Identifier Source: secondary_id

CA163-144

Identifier Type: -

Identifier Source: org_study_id