Urothelial Carcinoma Clinical Trial
Official title:
A Single Arm, Multicenter, Open-label Phase II Trial of Cabazitaxel as Second Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma
In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma.
For those patients with advanced bladder cancer who have progressed on a platinum based
regimen, no widely accepted standard second line therapy currently exists. Taxanes including
paclitaxel and docetaxel have exhibited limited clinical activity in this disease and are
sometimes given off study. Cabazitaxel is a novel semi-synthetic taxane with a low affinity
for the multidrug resistance 1 protein. In cell lines cabazitaxel is as potent as docetaxel,
but in tumor cells that are resistant to taxanes, cabazitaxel overcome taxanes resistance.
In recent clinical data, this drug was shown to have potent activity in patients with
metastatic prostate cancer resistant to docetaxel. Based on this phase III data, cabazitaxel
was recently approved in the US, Europe and in Israel for these patients. The main toxicity
of this taxane is neutropenia and diarrhea, thus primary prevention with GCSF may reduce the
main toxicity of this agent.
In this phase II multicenter study, the investigators aim to evaluate the efficacy and
tolerability of this novel taxane -cabazitaxel as single agent second-line chemotherapy for
metastatic urothelial carcinoma after failure of prior platinum-based chemotherapy.
The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2)
intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment
cycles are every 3 weeks. All patients will receive primary GCSF support.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03520231 -
Study Comparing Denosumab With Standard Treatment in Urothelial Cancer Patients With Bone Metastases
|
Phase 2 | |
| Recruiting |
NCT05775874 -
A Study to Evaluate the Safety and Efficacy of AZD4547 Combination With Tislelizumab in Patients With mUC
|
Phase 2 | |
| Recruiting |
NCT04623502 -
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
|
N/A | |
| Recruiting |
NCT04617756 -
Safety & Efficacy of Durvalumab+Neoadjuvant Chemotherapy for High-risk Urothelial Carcinoma of the Upper Urinary Tract
|
Phase 2 | |
| Recruiting |
NCT06116396 -
Liquid Biospy for Urinary Cancers
|
||
| Recruiting |
NCT05723991 -
Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma
|
Phase 4 | |
| Active, not recruiting |
NCT03039413 -
Copper Cu-64 TP3805 PET/CT in Imaging Patients With Urothelial Cancer Undergoing Surgery or Biopsy
|
Early Phase 1 | |
| Completed |
NCT02795156 -
Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations
|
Phase 2 | |
| Terminated |
NCT03915405 -
KHK2455 (IDO Inhibitor) Plus Avelumab in Adult Subjects With Advanced Bladder Cancer
|
Phase 1 | |
| Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 | |
| Completed |
NCT04452214 -
A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors
|
Phase 1 | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Recruiting |
NCT05911295 -
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
|
Phase 3 | |
| Terminated |
NCT01093066 -
Prospective Multicentric Evaluation of a Bladder Preservation Strategy
|
Phase 2 | |
| Terminated |
NCT01042795 -
Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
|
Phase 2 | |
| Recruiting |
NCT06022757 -
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03212404 -
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT04140526 -
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
|
Phase 1/Phase 2 |