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

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ClinicalTrials.gov Identifier: NCT00983801
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : September 19, 2012
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
R-Pharm

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stomach Neoplasms
Intervention Drug: Ixabepilone
Enrollment 58
Recruitment Details  
Pre-assignment Details Of 58 participants enrolled in this study, 6 failed screening criteria, and 52 received treatment.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Period Title: Overall Study
Started 52 [1]
Completed 52 [2]
Not Completed 0
[1]
Participants who received treatment.
[2]
Participants who were taken off treatment.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
< 65 years 40
>=65 years 12
< 50 years 9
>=50 years 43
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
56.5
(29.0 to 77.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
18
  34.6%
Male
34
  65.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
Chinese 23
Japanese 15
Korean 13
Asian Other 1
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
0 (normal activity) 20
1 (symptoms, but fully ambulatory) 32
[1]
Measure Description: 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.
1.Primary Outcome
Title Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description 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 Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.4
(6.9 to 28.1)
2.Secondary Outcome
Title Time to Response
Hide Description 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.
Time Frame Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)
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Hide Analysis Population Description
Participants who received at least 1 dose of study therapy and had a response of either CR or PR.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: weeks
8.9
(5.1 to 12.1)
3.Secondary Outcome
Title Duration of Response
Hide Description 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.
Time Frame From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)
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Hide Analysis Population Description
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.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(2.6 to 4.1)
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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).
Time Frame From the date of initiation of study therapy to the date of progression (up to 8.1 months).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(2.1 to 3.5)
5.Secondary Outcome
Title Percentage of Participants With Disease Control Rate
Hide Description 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.
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
65.4
(50.9 to 78.0)
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of study therapy.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
Death (due to disease progression) 16
Death (due to pneumonia) 1
Death within 30 days of last dose of study therapy 4
At least one SAE (Any GR) 30
At least one SAE (GR 3-4) 21
At least one DR SAE (Any GR) 12
At least one DR SAE (GR 3-4) 9
At least one AE (Any GR) 52
At least one AE (GR 3-4) 41
At least one DR AE (Any GR) 50
At least one DR AE (GR 3-4) 31
AEs leading to study drug discontinuation (Any GR) 10
AEs leading to study drug discontinuation (GR 3-4) 7
DRAEs leading to study drug discontinuation:Any GR 4
DRAEs leading to study drug discontinuation: GR3-4 4
Any Peripheral Neuropathy (Any GR) 33
Any Peripheral Neuropathy (GR 3-4) 4
DR Peripheral Neuropathy (Any GR) 32
DR Peripheral Neuropathy (GR 3-4) 4
7.Secondary Outcome
Title Number of Participants With Hematology Abnormalities
Hide Description 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.
Time Frame 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ixabepilone and had at least one measurement available during the study therapy period.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
WBC GR1 6
WBC GR2 17
WBC GR3 20
WBC GR4 5
ANC GR1 4
ANC GR2 7
ANC GR3 16
ANC GR4 21
Platelet Count GR1 18
Platelet Count GR2 3
Platelet Count GR3 4
Platelet Count GR4 0
Hemoglobin GR1 17
Hemoglobin GR2 23
Hemoglobin GR3 11
Hemoglobin GR4 0
8.Secondary Outcome
Title Number of Participants With Serum Chemistry Abnormalities
Hide Description 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.
Time Frame 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).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of ixabepilone. n=number of participants with at least 1 measurement available during the study therapy period.
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
ALP GR1 (n=49) 22
ALP GR2 (n=49) 1
ALP GR3 (n=49) 1
ALP GR4 (n=49) 1
AST GR1 (n=49) 9
AST GR2 (n=49) 0
AST GR3 (n=49) 0
AST GR4 (n=49) 0
ALT GR1 (n=50) 8
ALT GR2 (n=50) 1
ALT GR3 (n=50) 0
ALT GR4 (n=50) 0
Total bilirubin GR1 (n=49) 0
Total bilirubin GR2 (n=49) 3
Total bilirubin GR3 (n=49) 0
Total bilirubin GR4 (n=49) 0
Creatinine GR1 (n=51) 4
Creatinine GR2 (n=51) 1
Creatinine GR3 (n=51) 0
Creatinine GR4 (n=51) 0
9.Other Pre-specified Outcome
Title Number of Participants With Best Response as Assessed With Modified RECIST
Hide Description 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.
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description:
ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
Partial Response 8
Stable Disease 26
Progressive Disease 15
Unable to Determine (No tumor assessment) 1
Unable to Determine (Other) 2
Time Frame 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)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixabepilone 40 mg/m^2 IV
Hide Arm/Group Description ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
All-Cause Mortality
Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%)
Total   30/52 (57.69%) 
Blood and lymphatic system disorders   
NEUTROPENIA  1  3/52 (5.77%) 
FEBRILE NEUTROPENIA  1  2/52 (3.85%) 
Gastrointestinal disorders   
ABDOMINAL DISTENSION  1  1/52 (1.92%) 
NAUSEA  1  2/52 (3.85%) 
OBSTRUCTION GASTRIC  1  1/52 (1.92%) 
ILEUS  1  2/52 (3.85%) 
COLONIC OBSTRUCTION  1  1/52 (1.92%) 
MALABSORPTION  1  1/52 (1.92%) 
SMALL INTESTINAL OBSTRUCTION  1  1/52 (1.92%) 
VOMITING  1  2/52 (3.85%) 
ABDOMINAL PAIN  1  1/52 (1.92%) 
General disorders   
MUCOSAL INFLAMMATION  1  1/52 (1.92%) 
PYREXIA  1  3/52 (5.77%) 
Infections and infestations   
ANAL ABSCESS  1  1/52 (1.92%) 
PNEUMONIA  1  2/52 (3.85%) 
DEVICE RELATED INFECTION  1  1/52 (1.92%) 
NEUTROPENIC SEPSIS  1  1/52 (1.92%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  6/52 (11.54%) 
HYPONATRAEMIA  1  1/52 (1.92%) 
HYPOPHAGIA  1  2/52 (3.85%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  1/52 (1.92%) 
MUSCULAR WEAKNESS  1  1/52 (1.92%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
NEOPLASM MALIGNANT  1  10/52 (19.23%) 
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA EXERTIONAL  1  1/52 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ixabepilone 40 mg/m^2 IV
Affected / at Risk (%)
Total   51/52 (98.08%) 
Blood and lymphatic system disorders   
NEUTROPENIA  1  25/52 (48.08%) 
ANAEMIA  1  6/52 (11.54%) 
THROMBOCYTOPENIA  1  3/52 (5.77%) 
LYMPHOPENIA  1  3/52 (5.77%) 
LEUKOPENIA  1  12/52 (23.08%) 
Gastrointestinal disorders   
DIARRHOEA  1  20/52 (38.46%) 
ABDOMINAL DISTENSION  1  4/52 (7.69%) 
NAUSEA  1  15/52 (28.85%) 
CONSTIPATION  1  14/52 (26.92%) 
VOMITING  1  10/52 (19.23%) 
ABDOMINAL PAIN  1  10/52 (19.23%) 
STOMATITIS  1  7/52 (13.46%) 
General disorders   
CHEST PAIN  1  3/52 (5.77%) 
MUCOSAL INFLAMMATION  1  3/52 (5.77%) 
PYREXIA  1  8/52 (15.38%) 
FATIGUE  1  24/52 (46.15%) 
ASTHENIA  1  7/52 (13.46%) 
Investigations   
HAEMOGLOBIN DECREASED  1  4/52 (7.69%) 
WEIGHT DECREASED  1  11/52 (21.15%) 
Metabolism and nutrition disorders   
DECREASED APPETITE  1  33/52 (63.46%) 
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  11/52 (21.15%) 
BACK PAIN  1  7/52 (13.46%) 
PAIN IN EXTREMITY  1  6/52 (11.54%) 
MYALGIA  1  12/52 (23.08%) 
Nervous system disorders   
HYPOAESTHESIA  1  6/52 (11.54%) 
PERIPHERAL SENSORY NEUROPATHY  1  26/52 (50.00%) 
HEADACHE  1  3/52 (5.77%) 
DYSGEUSIA  1  6/52 (11.54%) 
DIZZINESS  1  8/52 (15.38%) 
Psychiatric disorders   
INSOMNIA  1  8/52 (15.38%) 
Respiratory, thoracic and mediastinal disorders   
COUGH  1  3/52 (5.77%) 
Skin and subcutaneous tissue disorders   
NAIL DISORDER  1  6/52 (11.54%) 
PRURITUS  1  9/52 (17.31%) 
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  4/52 (7.69%) 
ALOPECIA  1  35/52 (67.31%) 
RASH  1  19/52 (36.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
Responsible Party: R-Pharm
ClinicalTrials.gov Identifier: NCT00983801     History of Changes
Other Study ID Numbers: CA163-200
First Submitted: September 23, 2009
First Posted: September 24, 2009
Results First Submitted: June 20, 2012
Results First Posted: September 19, 2012
Last Update Posted: March 10, 2016