Clinical trial · Interventional
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.
NCT02251951CI-TRIAL-00019399completedPhase 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 investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction
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 and Gastro-Esophageal Junction (GEJ) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nab-Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nab-Paclitaxel
- description
- Abraxane
- interventionNames
- Drug: nab-Paclitaxel
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Disease evaluation every 8 weeks up to 108 weeks
- description
- Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response
Secondary outcomes (4)
- measure
- Disease control rate
- timeFrame
- Disease evaluation every 8 weeks up to 108 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years old * Disease progression after treatment with the DCF regimen * Assessable target lesion(s) as defined by RECIST criteria * ECOG performance status ≤ 1 * Estimated life expectancy more than 3 months * Serum bilirubin less than 1.5 times the upper normal limit * Aspartate Aminotransferase and Alanine Aminotransferase less than 2.5 times the upper normal limit * Creatinine Clearance ≥50 ml/min * Neutrophil count more than 1.5x 109 /L * Platelet count more than 100x 109 /L * Hemoglobin more than 8g/dL * Before patient enrollment, written informed consent must be given according to Good Clinical Practice guidelines and national/local regulations. Exclusion Criteria: * Gastrointestinal bleeding * Clinically relevant, symptomatic excessive amounts of ascites resulting in patient's discomfort * CNS metastases * Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment * Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment * Known hypersensitivity reaction to the component of the treatment * Active infection or malnutrition or bowel obstruction * Legal incapacity or limited legal capacity * Definite contraindications for the use of corticosteroids * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan * Chronic inflammation of the bowel * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment * Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent * Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer
References
Publications (0)
Data not yet available
No reference posted for this study.