NCT04525131

Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors

A Window of Opportunity Study to Characterize the Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: CicloMed LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be an open-label study to determine the safety, dose tolerance, pharmacokinetics, and pharmacodynamics of CPX-POM in patients with newly diagnosed or recurrent, untreated or intravesical treatment completed \>6 months before the current diagnosis, resectable tumors. Approximately 12 patients will be enrolled and treated with 900 mg/m2 CPX-POM administered IV over 20 minutes once per day for 5 days followed by TURBT on Day 5 after the fifth dose. TURBT will be performed 2 to 6 hours following drug administration on Day 5. Pretreatment bladder tumor tissues will be obtained at the time of in-office cystoscopy by cold cup biopsy within 4 weeks of TURBT. Posttreatment bladder tumor tissues will be obtained at TURBT. Bladder tumor tissues will undergo pathological evaluation at each site. Prior to administration of the first CPX-POM dose on Day 1, pre-dose blood (plasma) and urine (clean catch) samples will be collected. At the time of TURBT on Day 5, one 3-mL blood (plasma) sample and a urine specimen will be collected for measurement of CPX-POM concentrations. Patients will be followed for at least 30 days after the last dose of CPX-POM for safety

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	CPX-POM	CPX-POM

Timeline

• Start date: 2020-11-25
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2020-08-25
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study