Status:
COMPLETED
Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
Lead Sponsor:
R-Pharm
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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
- \>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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00983801
Start Date
November 1 2009
End Date
June 1 2011
Last Update
October 28 2020
Active Locations (9)
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1
Local Institution
Hong Kong, Hong Kong, B
2
Local Institution
Nagoya, Aichi-ken, Japan, 4648681
3
Local Institution
Sunto-Gun, Shizuoka, Japan, 4118777
4
Local Institution
Singapore, Singapore, 169610