Clinical trial · Interventional
Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
A Phase II Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer Previously Treated With Fluoropyrimidine-based Chemotherapy
NCT00983801CI-TRIAL-00047970completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to determine whether ixabepilone is effective in the treatment of unresectable or metastatic gastric cancer in Asian participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ixabepilone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ixabepilone
- interventionNames
- Drug: Ixabepilone
Primary outcomes (1)
- 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)
- description
- Percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) according to modified RECIST, as determined by investigator. CR: Disappearance of all evidence of target and non-target lesions. In case of lymph node, the lesions short axis of all nodes measuring \<10 mm. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. A 2-sided confidence interval (CI) was computed using Clopper-Pearson method.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.