Trial Outcomes & Findings for Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer (NCT NCT00983801)

Last Updated: 2020-10-28

Results Overview

Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring \<10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)

Results posted on

2020-10-28

Participant Flow

Of 58 participants enrolled in this study, 6 failed screening criteria, and 52 received treatment.

Participant milestones

Participant milestones
Measure	Ixabepilone 40 mg/m^2 IV ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Age, Customized < 65 years	40 participants n=5 Participants
Age, Customized >=65 years	12 participants n=5 Participants
Age, Customized < 50 years	9 participants n=5 Participants
Age, Customized >=50 years	43 participants n=5 Participants
Age, Customized	56.5 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	23 participants n=5 Participants
Race/Ethnicity, Customized Japanese	15 participants n=5 Participants
Race/Ethnicity, Customized Korean	13 participants n=5 Participants
Race/Ethnicity, Customized Asian Other	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 (normal activity)	20 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 (symptoms, but fully ambulatory)	32 participants n=5 Participants

PRIMARY outcome

Timeframe: During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (maximum time that any participant was on therapy was 30 weeks)

Population: Response-evaluable participants: Participants who received at least 1 dose of ixabepilone with measurable disease at baseline and right cancer diagnosis (presence of histologic or cytologic diagnosis of advanced or metastatic adenocarcinoma originating in the stomach or gastroesophageal junction).

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)	15.4 percentage of participants Interval 6.9 to 28.1

SECONDARY outcome

Timeframe: Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)

Population: Participants who received at least 1 dose of study therapy and had a response of either CR or PR.

Time to response is defined as the time in weeks from the first dose of study therapy until measurement criteria are first met for PR or CR (whichever status is recorded first). CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node lesions, the short axis of all nodes should measure \<10 mm. PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks of initial assessment.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=8 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Time to Response	8.9 weeks Interval 5.1 to 12.1

SECONDARY outcome

Timeframe: From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)

Population: Participants who received at least 1 dose of ixabepilone and had either CR or PR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment.

Defined as the period in months from the time measurement criteria are first met for PR or CR until the first date of documented PD or death. Refer to outcome measure 1 for CR and PR. PD=≥20% increase in the sum of LD of target lesions and an absolute increase of at least 5 mm of tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated by Kaplan-Meier product limit method and a 2-sided 95% CI for median duration was computed by Brookmeyer and Crowley method.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=8 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Duration of Response	3.1 months Interval 2.6 to 4.1

SECONDARY outcome

Timeframe: From the date of initiation of study therapy to the date of progression (up to 8.1 months).

Population: Participants who received at least 1 dose of ixabepilone. Participants who died without reporting prior progression were considered to have progressed on their death day. Participants who did not progress or die were censored on their last tumor assessment day. Participants without on-study tumor assessments were censored at start date of therapy.

PFS=the time interval from date of randomization to the earliest (first) progression or date of death. Participants who progressed or died were counted as events. PD=≥20% increase in sum of LD of target lesions and an absolute increase ≥5 mm in tumor size in reference to the smallest sum LD recorded at or following baseline or the appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Estimated using the Kaplan-Meier product-limit method for all treated participants and a 2-sided 95% CI for the median PFS was computed by Brookmeyer and Crowley method).

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Progression Free Survival (PFS)	2.8 months Interval 2.1 to 3.5

SECONDARY outcome

Defined as percentage of participants whose best response was PR, CR, or SD as determined by the investigator. SD=Neither PR or PD are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 1 for definition of CR or PR and refer to outcome measure 4 for definition of PD. A 2-sided 95% CI was computed using Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Percentage of Participants With Disease Control Rate	65.4 percentage of participants Interval 50.9 to 78.0

SECONDARY outcome

Timeframe: Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3 to 30 weeks)

Population: Participants who received at least 1 dose of study therapy.

AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade (GR) 3=Severe; and GR4=Life-threatening or disabling. DR=Drug-related. Any Peripheral Neuropathy includes peripheral sensory and motor neuropathies, including muscle weakness, and hypoaesthesia.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one AE (Any GR)	52 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Death (due to disease progression)	16 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Death (due to pneumonia)	1 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Death within 30 days of last dose of study therapy	4 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one SAE (Any GR)	30 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one SAE (GR 3-4)	21 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one DR SAE (Any GR)	12 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one DR SAE (GR 3-4)	9 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one AE (GR 3-4)	41 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one DR AE (Any GR)	50 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 At least one DR AE (GR 3-4)	31 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 AEs leading to study drug discontinuation (Any GR)	10 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 AEs leading to study drug discontinuation (GR 3-4)	7 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 DRAEs leading to study drug discontinuation:Any GR	4 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 DRAEs leading to study drug discontinuation: GR3-4	4 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Any Peripheral Neuropathy (Any GR)	33 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 Any Peripheral Neuropathy (GR 3-4)	4 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 DR Peripheral Neuropathy (Any GR)	32 participants
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 DR Peripheral Neuropathy (GR 3-4)	4 participants

SECONDARY outcome

Timeframe: Assessed once every week for first 3 weeks, as clinically indicated, start of each 3 week cycle (maximum time that any participant was on therapy was 30 weeks).

Population: Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.

Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. White blood cell (WBC):GR1=\<LLN-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3=\<2.0-1.0\*10\^9/L; GR4=\<1.0\*10\^9/L. Absolute Neutrophil Count (ANC):GR1=\<LLN-1.5\*10\^9 /L; GR2=\<1.5-1.0\*10\^9/L; GR3=\<1.0-0.5\*10\^9/L; GR4=\<0.5\*10\^9/L. Platelets:GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3=\<50.0-25.0\*10\^9/L, GR4=\<25.0\*10\^9/L. Hemoglobin:GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3=\<8.0-6.5g/dL, GR4=\<6.5g/dL. LLN=lower limit of normal.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Number of Participants With Hematology Abnormalities WBC GR1	6 participants
Number of Participants With Hematology Abnormalities WBC GR2	17 participants
Number of Participants With Hematology Abnormalities WBC GR3	20 participants
Number of Participants With Hematology Abnormalities WBC GR4	5 participants
Number of Participants With Hematology Abnormalities ANC GR1	4 participants
Number of Participants With Hematology Abnormalities ANC GR2	7 participants
Number of Participants With Hematology Abnormalities ANC GR3	16 participants
Number of Participants With Hematology Abnormalities ANC GR4	21 participants
Number of Participants With Hematology Abnormalities Platelet Count GR1	18 participants
Number of Participants With Hematology Abnormalities Platelet Count GR2	3 participants
Number of Participants With Hematology Abnormalities Platelet Count GR3	4 participants
Number of Participants With Hematology Abnormalities Platelet Count GR4	0 participants
Number of Participants With Hematology Abnormalities Hemoglobin GR1	17 participants
Number of Participants With Hematology Abnormalities Hemoglobin GR2	23 participants
Number of Participants With Hematology Abnormalities Hemoglobin GR3	11 participants
Number of Participants With Hematology Abnormalities Hemoglobin GR4	0 participants

SECONDARY outcome

Timeframe: Assessed within 2 weeks of first dose and every 3 weeks before therapy dose (maximum time that any participant was on therapy was 30 weeks).

Population: Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.

Grading: NCI CTCAE, Version 3.0. GR1=mild, GR2=moderate, GR3=severe, GR4=life threatening or disabling. Normal ranges provided by local laboratory and may also vary by age and sex. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST): GR1=\>ULN-2.5\*ULN; GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4=\>20.0\*ULN. Total bilirubin: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN. Creatinine: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. ULN=upper limit of normal.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Number of Participants With Serum Chemistry Abnormalities ALP GR1 (n=49)	22 participants
Number of Participants With Serum Chemistry Abnormalities ALP GR2 (n=49)	1 participants
Number of Participants With Serum Chemistry Abnormalities ALP GR3 (n=49)	1 participants
Number of Participants With Serum Chemistry Abnormalities ALP GR4 (n=49)	1 participants
Number of Participants With Serum Chemistry Abnormalities AST GR1 (n=49)	9 participants
Number of Participants With Serum Chemistry Abnormalities AST GR2 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities AST GR3 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities AST GR4 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities ALT GR1 (n=50)	8 participants
Number of Participants With Serum Chemistry Abnormalities ALT GR2 (n=50)	1 participants
Number of Participants With Serum Chemistry Abnormalities ALT GR3 (n=50)	0 participants
Number of Participants With Serum Chemistry Abnormalities ALT GR4 (n=50)	0 participants
Number of Participants With Serum Chemistry Abnormalities Total bilirubin GR1 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities Total bilirubin GR2 (n=49)	3 participants
Number of Participants With Serum Chemistry Abnormalities Total bilirubin GR3 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities Total bilirubin GR4 (n=49)	0 participants
Number of Participants With Serum Chemistry Abnormalities Creatinine GR1 (n=51)	4 participants
Number of Participants With Serum Chemistry Abnormalities Creatinine GR2 (n=51)	1 participants
Number of Participants With Serum Chemistry Abnormalities Creatinine GR3 (n=51)	0 participants
Number of Participants With Serum Chemistry Abnormalities Creatinine GR4 (n=51)	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment, assessed every 6 weeks (± 1 week) starting from the 1st dose of therapy until disease progression, or development of intolerable toxicity, for a maximum of 8 cycles (to a maximum follow up for tumor response of 30 weeks)

Best overall response that any participant can have is the best response recorded from the start of treatment until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). PR: At least 30% reduction from baseline in the sum of the LD of all target lesions. PR criteria should be met again after 4 weeks and before 6 weeks. Stable disease (SD)=Neither PR or progressive disease (PD) are met, taking the smallest sum of the LD recorded at baseline as reference. Refer to outcome measure 4 for definition of PD.

Outcome measures

Outcome measures
Measure	Ixabepilone 40 mg/m^2 IV n=52 Participants ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Number of Participants With Best Response as Assessed With Modified RECIST Partial Response	8 participants
Number of Participants With Best Response as Assessed With Modified RECIST Stable Disease	26 participants
Number of Participants With Best Response as Assessed With Modified RECIST Progressive Disease	15 participants
Number of Participants With Best Response as Assessed With Modified RECIST Unable to Determine (No tumor assessment)	1 participants
Number of Participants With Best Response as Assessed With Modified RECIST Unable to Determine (Other)	2 participants

Adverse Events

Ixabepilone 40 mg/m^2 IV

Serious events: 30 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ixabepilone 40 mg/m^2 IV n=52 participants at risk ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM MALIGNANT	19.2% 10/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Infections and infestations ANAL ABSCESS	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders NEUTROPENIA	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders ABDOMINAL DISTENSION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Metabolism and nutrition disorders DECREASED APPETITE	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders MUCOSAL INFLAMMATION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders NAUSEA	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Metabolism and nutrition disorders HYPONATRAEMIA	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Metabolism and nutrition disorders HYPOPHAGIA	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders OBSTRUCTION GASTRIC	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Infections and infestations PNEUMONIA	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders PYREXIA	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders ILEUS	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders COLONIC OBSTRUCTION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Infections and infestations DEVICE RELATED INFECTION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders MALABSORPTION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders VOMITING	3.8% 2/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders ABDOMINAL PAIN	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Infections and infestations NEUTROPENIC SEPSIS	1.9% 1/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)

Other adverse events

Other adverse events
Measure	Ixabepilone 40 mg/m^2 IV n=52 participants at risk ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Investigations HAEMOGLOBIN DECREASED	7.7% 4/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Nervous system disorders HYPOAESTHESIA	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	50.0% 26/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders ARTHRALGIA	21.2% 11/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders CHEST PAIN	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders DIARRHOEA	38.5% 20/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Nervous system disorders HEADACHE	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders NEUTROPENIA	48.1% 25/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders ABDOMINAL DISTENSION	7.7% 4/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Respiratory, thoracic and mediastinal disorders COUGH	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Metabolism and nutrition disorders DECREASED APPETITE	63.5% 33/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders MUCOSAL INFLAMMATION	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders NAUSEA	28.8% 15/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders ANAEMIA	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders BACK PAIN	13.5% 7/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Nervous system disorders DYSGEUSIA	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Skin and subcutaneous tissue disorders NAIL DISORDER	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders PYREXIA	15.4% 8/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders THROMBOCYTOPENIA	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders CONSTIPATION	26.9% 14/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	11.5% 6/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Skin and subcutaneous tissue disorders PRURITUS	17.3% 9/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Investigations WEIGHT DECREASED	21.2% 11/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Nervous system disorders DIZZINESS	15.4% 8/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders FATIGUE	46.2% 24/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders LYMPHOPENIA	5.8% 3/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	7.7% 4/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Skin and subcutaneous tissue disorders ALOPECIA	67.3% 35/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Psychiatric disorders INSOMNIA	15.4% 8/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders VOMITING	19.2% 10/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders ABDOMINAL PAIN	19.2% 10/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
General disorders ASTHENIA	13.5% 7/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Blood and lymphatic system disorders LEUKOPENIA	23.1% 12/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Musculoskeletal and connective tissue disorders MYALGIA	23.1% 12/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Skin and subcutaneous tissue disorders RASH	36.5% 19/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)
Gastrointestinal disorders STOMATITIS	13.5% 7/52 • Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on ixapebilone therapy was 10.5 weeks (range: 3-30 weeks)

Additional Information

BMS Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER