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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Treatments: Epothilones

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