Clinical trial · Interventional
Second-line Chemotherapy in Castration Resistant Prostate Cancer
Open, Single-arm, Multicenter, Phase II Trial Investigating the Safety of Biweekly Cabazitaxel in Metastatic Castration Resistant Prostate Cancer Patients Previously Treated With a Docetaxel-containing Regimen
- 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)
This study is designed to evaluate the safety of biweekly cabazitaxel for the treatment of metastatic castration resistant prostate cancer (mCRPC) patients previously treated with docetaxel containing regimen. The primary endpoint is safety. Secondary endpoints include time to treatment failure, response rate, overall survival and quality of life.
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cabacitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- acitive anticancer drug
- description
- single cytostatic agent, cabazitaxel every second week in the treatment of castration resistant metastatic prostate cancer after docetaxel
- interventionNames
- Drug: cabacitaxel
Primary outcomes (1)
- measure
- Safety and tolerabilty
- timeFrame
- every 2 weeks
- description
- NCI CTC-AE version 4 Adverse events in every organ systems and laborotory values (Grades from 0 to 5, 0=no adverse events, 5= dead)from baseline up to the end of the treatment
Secondary outcomes (1)
- measure
- Response rate
- timeFrame
- PSA every 6 week, tumor assesment every 12 week
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic castration resistant prostate cancer * Disease progression during or after docetaxel-containing regimen for mCRPC * Surgical or medical castration * WHO performance status \< 2 * Age \> 18 years * Adequate bone marrow, liver and renal functions: Hematology: * neutrophils \> 1.5 x 109/ l * hemoglobin \> 100 g/l * platelets \> 100 x 109/l Hepatic and renal functions: * total bilirubin \<1 x ULN * ALAT and ASAT \< 2.5 x ULN, alkaline phosphate \<6 x ULN.In the presence of extensive bone disease, alkaline phosphate \> 6 x ULN is accepted * creatinine \< 1.5 x ULN (ie NCI CTC-AE grade \< 1) Exclusion Criteria: * Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrollment * Prior therapy with radioisotopes * Other malignant disease (except superficial non-melanoma skin cancer) within the past 5 years * Serious liver disease * History of severe hypersensitivity reaction (grade \> 3) to polysorbate 80 containing drugs * Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who already are on these treatments) * Other serious illness or medical condition: * Serious cardiac disease; ischemic or thromboembolic cardiac disease, pulmonary emboli, cardiac infarction within 12 months * Active infection * Active peptic ulcer, uncontrolled diabetes mellitus or other contraindications for the use of corticosteroids * Auto-immune disease (lupus, scleroderma, rheumatoid polyarthritis) * Active grade \> 2 polyneuropathy
References
Publications (0)
Data not yet available