Clinical trial · Interventional
Cabazitaxel in Asian Patients With Advanced Gastric Cancer Who Failed Prior Chemotherapy
A Phase 2, Multicenter Study of Cabazitaxel Single Agent Administered as a 1-Hour Intravenous Infusion Every 3 Weeks to Evaluate the Safety, Tolerability and Anti-tumor Activity of Cabazitaxel in Patients With Advanced Gastric Adenocarcinoma Who Have Failed Prior Chemotherapy Regimens
- 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)
Primary Objective: \- To evaluate the anti-tumor activity of cabazitaxel by assessing objective tumor response rate (ORR) at the recommended dose (RD) when administered as a single agent every 3 weeks in patients with advanced gastric adenocarcinoma who have failed prior chemotherapy regimens Secondary Objectives: * To determine the RD of cabazitaxel when administered as a single agent every 3 weeks * To evaluate safety of cabazitaxel when administered as a single agent every 3 weeks * To estimate the overall survival (OS) and progression free survival (PFS) * To assess the pharmacokinetics (PK) profile of cabazitaxel in part 1
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 XRP6258 | Drug | Cabazitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabazitaxel
- description
- Cabazitaxel, several dosages
- interventionNames
- Drug: cabazitaxel XRP6258
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- Up to 2 years
Secondary outcomes (10)
- measure
- Overall survival (OS)
- timeFrame
- Up to a maximum of 2 years
- measure
- Progression free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically or cytologically confirmed unresectable or metastatic gastric adenocarcinoma including adenocarcinoma of gastroesophageal junction, which have failed 2 prior chemotherapy regimens. (For countries where a standard of care has not been established for the 2nd line treatment for advanced gastric cancer, those who failed 1 or 2 prior chemotherapy regimens can be included) * Signed informed consent Exclusion criteria: * Patients who have received \>2 prior systemic chemotherapy regimens for advanced gastric cancer. * For patients entering part 2, those without at least one measurable lesion at baseline according to Response Evaluation Criteria in Solid Tumors 1.1 criteria * Eastern Cooperative Oncology Group performance status \>1 * Age \<18 years * Inadequate organ and bone marrow function * Prior surgery, chemotherapy, targeted agents, investigational agents, or other anti-cancer therapy within 4 weeks prior to enrollment in the study * Prior radiation therapy within 6 weeks prior to enrollment (except palliative radiation for a local pain control) * Previous treatment with cabazitaxel * Known brain or leptomeningeal involvement of cancer * Patients with known acquired immunodeficiency syndrome (AIDS) related illness or known HIV infection requiring antiretroviral treatment. * Patients with active varicella zoster infection, or known hepatitis B or C infection. * History of severe hypersensitivity reaction ≥ grade 3 to drugs formulated with polysorbate 80 such as docetaxel The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
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