Clinical trial · Interventional
Phase II Study of ABI-007 for Gastric Cancer
Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.
NCT00661167CI-TRIAL-00006071completedPhase 2ClinicalTrials.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 is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABI-007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- ABI-007
- interventionNames
- Drug: ABI-007
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- During chemotherapy
Secondary outcomes (4)
- measure
- Safety
- timeFrame
- During chemotherapy
- measure
- Progression-free survival
- timeFrame
- Until progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed gastric adenocarcinoma * Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence * Age: 20 - 74 * At least one measurable lesion by RECIST criteria Exclusion Criteria: * History of Taxans use * Patients with another active malignancy * Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE) * Chronic treatment with steroids
References
Publications (1)
- DERIVEDSasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7. PMID 24716542