Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors
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|ClinicalTrials.gov Identifier: NCT04525131|
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : December 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: CPX-POM||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 25, 2020|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
IV over 20 minutes once per day
- Number of Participants with any Serious Adverse Events (SAEs) as assessed by (CTCAE) version 5.0 [ Time Frame: 35 days ]Incidence of Serious Adverse Events in subjects receiving CPX-POM
- Number of Participants with any Adverse Events (AEs) as assessed by (CTCAE) version 5.0 [ Time Frame: 35 days ]Incidence of Adverse Events in subjects receiving CPX-POM
- Evaluate the dose limiting toxicities (DLTs) of CPX-POM [ Time Frame: 35 days ]A DLT will include some Grade 3 or 4 AEs if deemed related to study drug. In addition, any patient who is unable to receive 80% of the expected dose of CPX-POM (i.e., patients who are unable to receive at least 4 of the 5 scheduled doses) because of AEs will be considered to have a DLT.
- Incidence of treatment related adverse events [ Time Frame: 35 days ]To determine the number of subjects with treatment related AEs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04525131
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Christina Hopkins 913-588-2566 firstname.lastname@example.org|
|Principal Investigator: John A Taylor III, MD, MSc|
|Principal Investigator:||John A Taylor III, MD, MSc||University of Kansas Medical Center|