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

R-Pharm

Status and phase: Completed; Phase 2

Conditions: Stomach Neoplasms

Treatments: Drug: Ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983801

CA163-200

Details and patient eligibility

About

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

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

Ixabepilone

Experimental group

Treatment:

Drug: Ixabepilone