Clinical trial NCT00983801: Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
Official title: A Phase II Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer Previously Treated With Fluoropyrimidine-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2009-09-24
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed gastric carcinoma originating from the stomach or gastroesophageal junction
* Must have unresectable or metastatic disease
* Asian ethnicity
* Must have failed prior fluoropyrimidine-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines

Exclusion Criteria:

* \>1 prior chemotherapy regimen in the metastatic setting or \>2 prior chemotherapy if subject also received adjuvant therapy
* Receipt of prior ixabepilone
* ECOG ≥2
* Known brain or meningeal metastasis
* Known viral hepatitis
* Prior taxane therapy
* Uncontrolled non-cancer related medical condition
* Second malignancy
* Peripheral neuropathy ≥ grade 2
* Inadequate hematologic, renal and hepatic function

Primary outcomes:
measure: Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST)
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)
Secondary outcomes:
measure: Time to Response
timeFrame: Assessed every 6 weeks (± 1 week) starting from the first dose of study therapy until CR or PR (up to 12.1 weeks.)
measure: Duration of Response
timeFrame: From the date of first PR or CR assessment to the date of progression, death, or last tumor assessment (maximum: 4.1 months)
measure: Progression Free Survival (PFS)
timeFrame: From the date of initiation of study therapy to the date of progression (up to 8.1 months).
measure: Percentage of Participants With Disease Control Rate
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)
measure: 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
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)
measure: Number of Participants With Hematology Abnormalities
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).
measure: Number of Participants With Serum Chemistry Abnormalities
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).
Other outcomes:
measure: Number of Participants With Best Response as Assessed With Modified RECIST
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)
Locations:
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Sunto-Gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan Hsien
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: