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

NCT04525131 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CPX-POM-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Bladder Cancer

Keywords

Newly diagnosed or recurrent bladder tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Any Serious Adverse Events (SAEs)

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

  35 days

• Number of Participants With Any Adverse Events (AEs)

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

  35 days

• Evaluate the Dose Limiting Toxicities (DLTs) of CPX-POM

  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.

  35 days

Secondary Outcomes (1)

• Incidence of Treatment Related Adverse Events

  35 days

Study Arms (1)

CPX-POM

EXPERIMENTAL

IV over 20 minutes once per day

Drug: CPX-POM

Interventions

CPX-POM DRUG

CPX-POM

CPX-POM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is male or female aged ≥18 years.
• Patient provided signed and dated informed consent prior to initiation of any study procedures.
• Patient is likely to have a new bladder tumor based on clinical presentation or is at high risk for tumor recurrence based on previous history.
• Patient has a cystoscopically confirmed bladder tumor and will be scheduled to undergo TURBT.
• Patient has not received prior treatment for bladder cancer or completed their last intravesical therapy \>6 months before screening.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
• Patient has a predicted life expectancy of ≥3 months.
• Patient has adequate renal function (creatinine ≤1.5 × the upper limit of the normal range (ULN) or an estimated glomerular filtration rate (eGFR) of \>30 mL/min/1.73 m2).
• Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 × ULN, aspartate aminotransferase (AST) ≤3 × ULN and /or alanine aminotransferase (ALT) ≤3 × ULN.
• Patient has adequate bone marrow function, as evidenced by hemoglobin ≥9.0 g/dL in the absence of transfusion within the previous 72 hours, platelet count ≥100×10\^9cells/L, and absolute neutrophil count (ANC) ≥1.5×10\^9 cells/L.
• Patient has no significant ischemic heart disease or myocardial infarction within 6 months before the first dose of CPX-POM and currently has adequate cardiac function, as evidenced by a left ventricular ejection fraction of \>50% as assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO); and corrected QT interval by Fridericia's correction formula (QTcF) \<450 msec for males and \<470 msec for females. The eligibility of patients with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the Sponsor in consultation with the Medical Monitor.
• Patient and his/her partner agree to use adequate contraception after providing written informed consent through 3 months after the last dose of CPX-POM, as follows:
• For women: Negative pregnancy test during Screening and at Day 1 of each treatment cycle and compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile or postmenopausal.
• For men: Compliant with a medically-approved contraceptive regimen during and for 3 months after the treatment period or documented to be surgically sterile. Men whose sexual partners are of child-bearing potential must agree to use 2 methods of contraception prior to study entry, during the study, and for 3 months after the treatment period.
• Patient is willing and able to participate in the study and comply with all study requirements.

You may not qualify if:

• Patients received prior intravesical therapy for bladder cancer within ≤6 months of the current diagnosis.
• Patients must not have had any of the following within 6 months before study drug administration:
• Myocardial infarction
• Severe/unstable angina
• Symptomatic congestive heart failure
• Cerebrovascular accident or transient ischemic attack, or
• Pulmonary embolism
• Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 grade 2.
• Evidence of New York Heart Association (NYHA) functional class III or IV heart disease.
• Uncontrolled hypertension (\>150/100 mmHg despite optimal medical therapy).
• Patient has an uncontrolled or severe intercurrent medical condition. The decision to exclude a patient from the study for an uncontrolled or severe intercurrent medical condition will be made by the Principal Investigator. Examples could include epilepsy, resistant infection, or any other neurological disease that would make clinical assessment difficult.
• Patient underwent major surgery or radiation therapy within 4 weeks before the first dose of CPX-POM or received an investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the first dose of CPX-POM. A minimum of 10 days between termination of the investigational drug and administration of CPX-POM is required.
• If female, patient is pregnant or breast-feeding.
• Patient has evidence of a serious active infection (e.g., infection requiring treatment with IV antibiotics).
• Patient has a known, active Hepatitis A infection.

Sponsors & Collaborators

• CicloMed LLC: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Weir SJ, Dandawate P, Standing D, Bhattacharyya S, Ramamoorthy P, Rangarajan P, Wood R, Brinker AE, Woolbright BL, Tanol M, Ham T, McCulloch W, Dalton M, Reed GA, Baltezor MJ, Jensen RA, Taylor JA 3rd, Anant S. Fosciclopirox suppresses growth of high-grade urothelial cancer by targeting the gamma-secretase complex. Cell Death Dis. 2021 May 31;12(6):562. doi: 10.1038/s41419-021-03836-z.

  PMID: 34059639 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John A Taylor
• Organization: University of Kansas Medical Center

jtaylor27@kumc.edu

9135888170

Study Officials

• John A Taylor III, MD, MSc

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 25, 2020
• Study Start: November 25, 2020
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Locations

US (1)