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

Conditions

• Locally Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg — 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 — 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 — 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 — 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2008

Status verified

Feb 2016

Primary completion

Jun 30, 2010

Completion

Jun 30, 2010

Study Design

Enrollment

13 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg
  Dose Level 1
• Experimental: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg
  Dose Level 2
• Experimental: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg
  Dose Level 3
• Experimental: Ixabepilone + Lapatinib + Capecitabine
  Triplet Combination

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib [ Time Frame: Days 1 through 21 ]

Locations (1)

Find similar trials in New Brunswick, NJ