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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00634088
Registration number
NCT00634088
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
10/03/2016
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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EURDRACT: 2007-004123-38
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Secondary ID [2]
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CA163-144
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Metastatic Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg
Treatment: Drugs - Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg
Treatment: Drugs - Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg
Treatment: Drugs - Ixabepilone + Lapatinib + Capecitabine
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
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib
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Assessment method [1]
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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.
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Timepoint [1]
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Days 1 through 21
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Primary outcome [2]
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MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine
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Assessment method [2]
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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 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.
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Timepoint [2]
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Days 1 through 21
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Secondary outcome [1]
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Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Treatment-related AEs, Treatment-related AEs (Grade 3 or 4), Peripheral Neuropathy (PN), PN (Grade 3 or 4)
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Assessment method [1]
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AE=Any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical event that results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, important, a congenital anomaly/birth defect; or requires or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment. Common Terminology Criteria (CTC) Grade 3=severe; Grade 4=life-threatening or disabling.
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Timepoint [1]
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Baseline to Day 21, continuously
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Secondary outcome [2]
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Number of Participants With DLT
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Assessment method [2]
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DLT=Any of the following events, attributable to study drug and occurring within 21 days after ixabepilone administration: Grade 3 or 4 nausea, vomiting, or diarrhea despite the use of adequate medical intervention; other Grade 3 or greater nonhematologic toxicity requiring removal from study drug; recovery from study drug-related toxicity that delayed scheduled retreatment for longer than 3 weeks; Grade 4 neutropenia for 5 or more consecutive days or Grade 3 or 4 neutropenia of any duration with sepsis or fever; thrombocytopenia or bleeding requiring platelet transfusion.
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Timepoint [2]
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Baseline to Day 21, continuously
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Secondary outcome [3]
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Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade
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Assessment method [3]
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CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC (c/uL): Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count (c/uL): Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0*10^9/L; Hemoglobin (g/dL): Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.
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Timepoint [3]
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Baseline and weekly from Days 1 to 21 (Cycle 1)
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Secondary outcome [4]
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Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade
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Assessment method [4]
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CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. ALT(U/L) Gr 1:>ULN-2.5*ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; AST(U/L) Gr 1:>ULN-2.5* ULN,Gr 2:>2.5-5.0*ULN,Gr 3:>5.0-20.0*ULN,Gr 4:>20.0* ULN; ALP(U/L)Gr 1:>ULN-2.5*ULN, Gr 2:>2.5-5.0*ULN, Gr 3:>5.0-20.0*ULN, Gr 4:>20.0*ULN; Creatinine (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-6.0*ULN, Gr 4:>6.0*ULN; Total bilirubin (mg/dL): Gr 1:>ULN-1.5*ULN, Gr 2:>1.5-3.0*ULN, Gr 3:>3.0-10.0*ULN, Gr 4:>10.0*ULN
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Timepoint [4]
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At baseline and within 72 hours of Day 1 of 21-day cycle
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Secondary outcome [5]
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Maximum Concentration of Ixabepilone
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Assessment method [5]
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Timepoint [5]
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Day 1 of 21-day cycle
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Secondary outcome [6]
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Area Under the Concentration-time Curve From 0 to Infinity (AUC[INF]) and AUC From 0 to Last Quantifiable Concentration (AUC[O-T] of Ixabepilone
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Assessment method [6]
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Timepoint [6]
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Day 1 of 21-day cycle
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Secondary outcome [7]
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Terminal Half-life of Ixabepilone
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Assessment method [7]
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Timepoint [7]
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Day 1 of 21-day cycle
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Secondary outcome [8]
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Time to Peak Concentration of Ixabepilone
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Assessment method [8]
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Timepoint [8]
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Day 1 of 21-day cycle
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Secondary outcome [9]
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Volume of Distribution at Steady State of Ixabepilone
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Assessment method [9]
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Timepoint [9]
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Day 1 of 21-day cycle
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Secondary outcome [10]
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Overall Tumor Response By Number of Participants
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Assessment method [10]
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Target lesion criteria: Complete Response(CR)=Disappearance of all clinical and radiologic evidence of target lesions; Partial Response (PR)=A 30% or greater decrease in the sum of longest diameter(LD) of all lesions in reference to the baseline sum LD. Stable Disease (SD)=Insufficient increase to qualify for Progressive Disease (PD) and insufficient shrinkage to qualify for PR; PD=A 20% or greater increase in the sum of LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline.
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Timepoint [10]
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Baseline and Day 21 (21-day cycle)
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Secondary outcome [11]
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Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib
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Assessment method [11]
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Duration of response is measured from the time in months that measurement criteria are first met for PR or CR, whichever is recorded first, until the date of documented PD or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment.
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Timepoint [11]
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First occurrence of PR or CR to PD or Death (no average, as no data available)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2010
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Sample size
Target
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Local Institution - Brisbane
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Recruitment postcode(s) [1]
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4101 - Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New Jersey
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Country [2]
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Italy
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State/province [2]
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Modena
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
R-Pharm
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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GlaxoSmithKline
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00634088
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00634088
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