Clinical trial · Interventional
Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Gastric Cancer
Multicentre, Phase II Study With Cabazitaxel in Previously Treated Patients With Advanced or Metastatic Adenocarcinoma of the Oesophagogastric Junction and Stomach
NCT01956149CI-TRIAL-00032561completedPhase 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)
Single-arm study to determine disease control rate in second- (or later) line treatment with cabazitaxel after the failure of palliative primary treatment.
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 |
|---|---|---|---|
| Cabazitaxel | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabazitaxel
- description
- Cabazitaxel 20 mg/m2 over 1 hour i.v., repeated on day 22
- interventionNames
- Drug: Cabazitaxel
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- up to 17 months
- description
- Patients are staged every 6 weeks during therapy (after cycle 2, 4 and 6, i.e. up to 18 weeks) and during follow-up (up to 12 months)
Secondary outcomes (6)
- measure
- Overall survival (OS)
- timeFrame
- up to 17 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed inoperable and/or metastatic adenocarcinoma of the oesophagogastric junction or stomach 2. Progression of a measurable lesion (RECIST) on previous palliative chemotherapy. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs \< 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line. 3. Male and female patients aged \> 18 years 4. ECOG ≤ 1 5. neutrophils ≥ 1500/µl 6. Haemoglobin ≥ 9 g/dl 7. Platelets ≥ 100,000/µl 8. AST/SGOT and/or ALT/SGPT ≤2.5 x ULN; 9. Total bilirubin ≤1.0 x ULN 10. Serum creatinine ≤ 1.5 times the normal value, or creatinine clearance ≥ 60 ml/min 11. Written patient informed consent Exclusion Criteria: 1. A history of severe hypersensitivity to taxanes (≥ grade 3) or to medicinal products containing polysorbate 80 (≥ grade 3) 2. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure 3. Malignant secondary disease dating back \< 5 years (exceptions: in situ cervical carcinoma, appropriately treated basal cell carcinoma of the skin) 4. Severe secondary internal diseases, including uncontrolled diabetes mellitus or an acute infection 5. Concomitant medication or planned treatment with strong CYP450 3A4/5 inducers or inhibitors (list of medicinal products in the appendix) or the relevant medicinal products were not discontinued a minimum of one week before treatment 6. Peripheral polyneuropathy \> NCI grade II 7. Severe hepatic impairment (AST/ALT \> 2.5 x ULN, , bilirubin \> 1 x ULN) 8. Chronic inflammatory bowel disease 9. Participation in another study 10. Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.