| Primary | Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of Ixabepilone When Administered With Lapatinib | 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. | Because the study was terminated due to insufficient enrollment, MTD was not achieved. | Posted | | | | | | Days 1 through 21 | | | | ID | Title | Description |
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| OG000 | All Treated | All participants who received at least 1 dose of ixabepilone or lapatinib. |
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| Secondary | 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) | 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. | All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine. | Posted | | Number | | Participants | | Baseline to Day 21, continuously | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d |
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| Secondary | Number of Participants With DLT | 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. | All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine. | Posted | | Number | | Participants | | Baseline to Day 21, continuously | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. |
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| Secondary | Number of Participants With Abnormalities in Hematology Laboratory Results by Worst CTC Grade | CTC, Version 3.0 used to assess parameters. ULN=upper level of normal among all laboratory ranges. WBC (c/L): Grade (Gr)1:\ | All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine. | Posted | | Number | | Participants | | Baseline and weekly from Days 1 to 21 (Cycle 1) | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. |
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| Secondary | Number of Participants With Abnormalities in Serum Chemistry Laboratory Results by Worst CTC Grade | 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 | All participants who received at least 1 dose of ixabepilone and either lapatinib or capecitabine. | Posted | | Number | | Participants | | At baseline and within 72 hours of Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. |
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| Secondary | Maximum Concentration of Ixabepilone | | Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available. | Posted | | Geometric Mean | Standard Deviation | ng/mL | | Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. | | OG002 | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 daily, orally once a day, for a 21-day cycle. |
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| Secondary | 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 | | Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available. | Posted | | Geometric Mean | Standard Deviation | ng*h/mL | | Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. | | OG002 | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d |
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| Secondary | Terminal Half-life of Ixabepilone | | Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available. | Posted | | Mean | Standard Deviation | Hours | | Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. | | OG002 | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 daily, orally once a day, for a 21-day cycle. |
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| Secondary | Time to Peak Concentration of Ixabepilone | | Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available. | Posted | | Median | Full Range | Hours | | Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. | | OG002 | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 daily, orally once a day, for a 21-day cycle. |
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| Secondary | Volume of Distribution at Steady State of Ixabepilone | | Participants who received ixabepilone with lapatinib treatment and had pharmacokinetic parameters available. | Posted | | Mean | Standard Deviation | Liters | | Day 1 of 21-day cycle | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. | | OG002 | Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 daily, orally once a day, for a 21-day cycle. |
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| Primary | MTD and RP2D of Ixabepilone When Administered With Lapatinib Plus Capecitabine | 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. | Because the study was terminated due to insufficient enrollment, no participants received the triplet combination. | Posted | | | | | | Days 1 through 21 | | | | ID | Title | Description |
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| OG000 | All Treated | All participants who received at least 1 dose of ixabepilone or lapatinib. |
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| Secondary | Overall Tumor Response By Number of Participants | 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. | All participants with measurable disease at baseline per RECIST guidelines, with the exception of those with an incorrect diagnosis. | Posted | | Number | | Participants | | Baseline and Day 21 (21-day cycle) | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. |
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| Secondary | Duration of Response of Combination Treatment With Ixabepilone Plus Lapatinib | 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. | Because the study was terminated due to insufficient enrollment, the duration of response could not be analyzed. | Posted | | | | | | First occurrence of PR or CR to PD or Death (no average, as no data available) | | | | ID | Title | Description |
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| OG000 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg/d | Lapatinib, 1000 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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 intravenous (IV) infusion. Lapatinib, 1000 mg, administered daily, orally once a day, for a 21-day cycle. | | OG001 | Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg/d | Lapatinib, 1250 mg, administered daily, orally once a day, at least 1 hour before or after a meal, for 7 to 14 consecutive days prior to first administration of ixabepilone (Day 1). After 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, 1250 mg, administered daily, orally once a day, for a 21-day cycle. |
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