Phase 2
N=52
Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
Stomach Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00983801 ↗Enrolled (actual)
52
Serious AEs
57.7%
Results posted
Sep 2012
Primary outcome: Primary: Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) — 15.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ixabepilone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- R-Pharm
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (RECIST) |
15.4 | — |
| SECONDARY Time to Response |
8.9 | — |
| SECONDARY Duration of Response |
3.1 | — |
| SECONDARY Progression Free Survival (PFS) |
2.8 | — |
| SECONDARY Percentage of Participants With Disease Control Rate |
65.4 | — |
| SECONDARY 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 |
16; 1; 4; 30; 21; 12 | — |
| SECONDARY Number of Participants With Hematology Abnormalities |
6; 17; 20; 5; 4; 7 | — |
| SECONDARY Number of Participants With Serum Chemistry Abnormalities |
22; 1; 1; 1; 9; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00983801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.