Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors
NCT04525131 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-06-18
Summary
This is a phase II, single center open label to determine safety, dose tolerance, PK and PD of the recommended Phase 2 dose (RP2D) of CPX-POM administered in patients with any newly diagnosed or recurrent bladder tumors.
Conditions
Interventions
- DRUG
-
CPX-POM
CPX-POM
Sponsors & Collaborators
-
CicloMed LLC
lead INDUSTRY
Principal Investigators
-
John A Taylor III, MD, MSc · University of Kansas Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-25
- Primary Completion
- 2022-12-30
- Completion
- 2023-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the Treatment Urothelial Carcinoma of the Bladder
NCT02202772 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer
NCT06337305 ·Status: COMPLETED
-
Longitudinal Bladder Cancer Study for Tumour Recurrence
NCT05080998 ·Status: RECRUITING
-
Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
NCT03319745 ·Status: COMPLETED ·Phase: PHASE2
-
Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
NCT01050504 ·Status: RECRUITING
-
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)
NCT06211764 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
NCT00045630 ·Status: COMPLETED ·Phase: PHASE2
-
S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
NCT02177695 ·Status: COMPLETED ·Phase: PHASE2
-
Intravesical Gemcitabine Instillation Followed by Transurethral Resection for the Treatment of Patients With Superficial Bladder Cancer at Low Risk.
NCT00191711 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)
NCT03664258 ·Status: COMPLETED
-
Clinical Evaluation of a Test for Monitoring the Recurrence of Bladder Cancer
NCT03125460 ·Status: COMPLETED
-
Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer
NCT05982561 ·Status: RECRUITING
-
Neoadjuvant Rapamycin in Patients Undergoing Radical Cystectomy
NCT01827618 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Window of Opportunity Phase I Study of UGN-201 in Patients With Bladder Cancer Undergoing Radical Cystectomy Protocol #: 2021-0630
NCT05055050 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer
NCT04289779 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer 2
NCT07225127 ·Status: RECRUITING
-
Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By Surgery
NCT00268450 ·Status: TERMINATED ·Phase: PHASE2
-
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer
NCT00003129 ·Status: COMPLETED ·Phase: PHASE2
-
Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
NCT04100733 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin
NCT04387461 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer
NCT06919965 ·Status: RECRUITING ·Phase: PHASE3
-
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
NCT02793128 ·Status: COMPLETED ·Phase: PHASE3
-
Cystoscopic Evaluation Predicting pT0 Urothelial Carcinoma of the Bladder
NCT02968732 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Window of Opportunity Study of Pembrolizumab Alone and in Combinations in Bladder Cancer
NCT03978624 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
NCT02351739 ·Status: COMPLETED ·Phase: PHASE2