Bladder CancerPhase 2NCT04525131
Safety, Dose Tolerance, Pharmacokinetics, Pharmacodynamics of CPX-POM in Patients With Newly Diagnosed or Recurrent Bladder Tumors
A Phase 2 study testing CPX-POM in people with Bladder Cancer, run by CicloMed LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- CPX-POM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 30 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- 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
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- 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.
- Patient has known human immunodeficiency virus (HIV) or Hepatitis B, or C infection, as such patients may be at increased risk for toxicity due to concomitant treatment and disease-related symptoms may preclude accurate assessment of the safety of CPX POM.
- Patient has an important medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.
- Patient is taking warfarin.
- Patients may not have another malignancy that could interfere with the evaluation of safety or efficacy of the study drug. Patients with a prior malignancy will be allowed without approval in the following circumstances:
- Not currently active and diagnosed at least 3 years prior to the date of registration.
- Non-invasive diseases such as low risk cervical cancer or any cancer in situ.
- Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy), and in which no chemotherapy was indicated.(e.g., low/intermediate risk prostate cancer, etc.).
- Non-muscle invasive bladder cancer (NMIBC) for which treatment was completed >6 months before the current diagnosis.
- Patient has known allergy or hypersensitivity to any component of CPX-POM.
- Patient is taking any iron replacement therapy administered IV, intramuscularly, or orally due to the potential for loss of anticancer activity due to drug and/or metabolites chelating iron.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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
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.
Read the 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
- Being tested
- CPX-POM
- Keywords
- Newly diagnosed or recurrent bladder tumors
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-POMDrug
CPX-POM
| Study group | Role | What they receive |
|---|---|---|
| CPX-POM | Experimental | IV over 20 minutes once per day Receives: Drug: CPX-POM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 35 days
Secondary outcomes (1)
Incidence of Treatment Related Adverse Events
To determine the number of subjects with treatment related AEs
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start25 Nov 2020
- Primary completion30 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- CicloMed LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John A Taylor III, MD, MSc, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525131
- Sponsor's protocol ID
- CPX-POM-002
- Status last verified
- May 2024
- First submitted
- 11 Aug 2020
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34059639
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04525131
- Acronym / sponsor ID
- CPX-POM-002
- Conditions
- Bladder Cancer
- Keywords
- Newly diagnosed or recurrent bladder tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- CicloMed LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPX-POM | Experimental | Drug: CPX-POMIV over 20 minutes once per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (26 listed)
- Patients who meet any of the following exclusion criteria are not to be enrolled in this study.
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPX-POMCPX-POM | Drug | CPX-POM |
Primary outcome
Number of Participants With Any Serious Adverse Events (SAEs)
Time frame: 35 days
Incidence of Serious Adverse Events in subjects receiving CPX-POM as assessed by (CTCAE) version 5.0
Number of Participants With Any Adverse Events (AEs)
Time frame: 35 days
Incidence of Adverse Events in subjects receiving CPX-POM as assessed by (CTCAE) version 5.0
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.
1 secondary outcome
Incidence of Treatment Related Adverse Events
Time frame: 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34059639Weir 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Taylor III, MD, MSc principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPX-POM in people with Bladder Cancer, run by CicloMed LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Serious Adverse Events (SAEs) (time frame: 35 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.