Trial Outcomes & Findings for Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors (NCT NCT04525131)

NCT ID: NCT04525131

Last Updated: 2024-06-18

Results Overview

Incidence of Serious Adverse Events in subjects receiving CPX-POM as assessed by (CTCAE) version 5.0

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

35 days

Results posted on

2024-06-18

Participant Flow

Participant milestones

Participant milestones
Measure	CPX-POM IV over 20 minutes once per day CPX-POM: CPX-POM
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPX-POM n=12 Participants IV over 20 minutes once per day CPX-POM: CPX-POM
Age, Continuous	69.41 years STANDARD_DEVIATION 10.01 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 35 days

Population: safety population

Incidence of Serious Adverse Events in subjects receiving CPX-POM as assessed by (CTCAE) version 5.0

Outcome measures

Outcome measures
Measure	CPX-POM n=12 Participants IV over 20 minutes once per day CPX-POM: CPX-POM
Number of Participants With Any Serious Adverse Events (SAEs)	1 Participants

PRIMARY outcome

Timeframe: 35 days

Population: safety population

Incidence of Adverse Events in subjects receiving CPX-POM as assessed by (CTCAE) version 5.0

Outcome measures

Outcome measures
Measure	CPX-POM n=12 Participants IV over 20 minutes once per day CPX-POM: CPX-POM
Number of Participants With Any Adverse Events (AEs)	9 Participants

PRIMARY outcome

Timeframe: 35 days

Population: Safety population

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.

Outcome measures

Outcome measures
Measure	CPX-POM n=12 Participants IV over 20 minutes once per day CPX-POM: CPX-POM
Evaluate the Dose Limiting Toxicities (DLTs) of CPX-POM	2 Participants

SECONDARY outcome

Timeframe: 35 days

Population: Safety population

To determine the number of subjects with treatment related AEs

Outcome measures

Outcome measures
Measure	CPX-POM n=12 Participants IV over 20 minutes once per day CPX-POM: CPX-POM
Incidence of Treatment Related Adverse Events	4 Participants

Adverse Events

CPX-POM

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CPX-POM n=12 participants at risk IV over 20 minutes once per day CPX-POM: CPX-POM
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 1/12 • 35 days

Other adverse events

Other adverse events
Measure	CPX-POM n=12 participants at risk IV over 20 minutes once per day CPX-POM: CPX-POM
Nervous system disorders Dizziness	25.0% 3/12 • 35 days
Nervous system disorders Somnolence	16.7% 2/12 • 35 days
Nervous system disorders Amnesia	8.3% 1/12 • 35 days
Nervous system disorders Headache	8.3% 1/12 • 35 days
Nervous system disorders Hypersomnia	8.3% 1/12 • 35 days
General disorders Fatigue	16.7% 2/12 • 35 days
General disorders Gait disturbance	8.3% 1/12 • 35 days
General disorders Injection site reaction	8.3% 1/12 • 35 days
Psychiatric disorders Confusional state	25.0% 3/12 • 35 days
Vascular disorders Hypertension	16.7% 2/12 • 35 days
Gastrointestinal disorders Nausea	8.3% 1/12 • 35 days
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • 35 days
Renal and urinary disorders Haematuria	8.3% 1/12 • 35 days

Additional Information

Dr. John A Taylor

University of Kansas Medical Center

Phone: 9135888170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor and the PI plan to publish the data.
Publication restrictions are in place

Restriction type: OTHER