Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Vial, Injection, Intravenous (IV), 40 mg/m\^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.

Ixabepilone

Bristol-Myers Squibb

The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.

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

A Phase II Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer Previously Treated With Fluoropyrimidine-based Chemotherapy

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.

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.

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.

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.

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).

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.

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.

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.

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.

R-Pharm

ixabepilone 40 mg/m\^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.

Ixabepilone 40 mg/m^2 IV

< 65 years

>=65 years

< 50 years

>=50 years

Age, Customized

Sex: Female, Male

Chinese

Japanese

Korean

Asian Other

Race/Ethnicity, Customized

0 (normal activity)

1 (symptoms, but fully ambulatory)

The ECOG PS is used to assess disease severity. A score of 0 is normal activity; 1=symptoms, but fully ambulatory; 2=symptomatic, but in bed \<50% of the day; 3=needs to be in bed \> 50% of the day, but not bedridden; 4=unable to get out of bed; 5=dead.

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

BMS Study Director

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).

Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)

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

Time to Response

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.

Duration of Response

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.

Progression Free Survival (PFS)

Percentage of Participants With Disease Control Rate

Death (due to disease progression)

Death (due to pneumonia)

Death within 30 days of last dose of study therapy

At least one SAE (Any GR)

At least one SAE (GR 3-4)

At least one DR SAE (Any GR)

At least one DR SAE (GR 3-4)

At least one AE (Any GR)

At least one AE (GR 3-4)

At least one DR AE (Any GR)

At least one DR AE (GR 3-4)

AEs leading to study drug discontinuation (Any GR)

AEs leading to study drug discontinuation (GR 3-4)

DRAEs leading to study drug discontinuation:Any GR

DRAEs leading to study drug discontinuation: GR3-4

Any Peripheral Neuropathy (Any GR)

Any Peripheral Neuropathy (GR 3-4)

DR Peripheral Neuropathy (Any GR)

DR Peripheral Neuropathy (GR 3-4)

Participants who received at least 1 dose of study therapy.

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

Partial Response

Stable Disease

Progressive Disease

Unable to Determine (No tumor assessment)

Unable to Determine (Other)

Number of Participants With Best Response as Assessed With Modified RECIST

WBC GR1

WBC GR2

WBC GR3

WBC GR4

ANC GR1

ANC GR2

ANC GR3

ANC GR4

Platelet Count GR1

Platelet Count GR2

Platelet Count GR3

Platelet Count GR4

Hemoglobin GR1

Hemoglobin GR2

Hemoglobin GR3

Hemoglobin GR4

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

Number of Participants With Hematology Abnormalities

ALP GR1 (n=49)

ALP GR2 (n=49)

ALP GR3 (n=49)

ALP GR4 (n=49)

AST GR1 (n=49)

AST GR2 (n=49)

AST GR3 (n=49)

AST GR4 (n=49)

ALT GR1 (n=50)

ALT GR2 (n=50)

ALT GR3 (n=50)

ALT GR4 (n=50)

Total bilirubin GR1 (n=49)

Total bilirubin GR2 (n=49)

Total bilirubin GR3 (n=49)

Total bilirubin GR4 (n=49)

Creatinine GR1 (n=51)

Creatinine GR2 (n=51)

Creatinine GR3 (n=51)

Creatinine GR4 (n=51)

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

Number of Participants With Serum Chemistry Abnormalities

Overall Study

Spots Global Cancer Trial Database for Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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