| Eligibility |
Inclusion Criteria:
1. Patient is male or female aged =18 years.
2. Patient provided signed and dated informed consent prior to initiation of any study
procedures.
3. 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.
4. Patient has a cystoscopically confirmed bladder tumor and will be scheduled to undergo
TURBT.
5. Patient has not received prior treatment for bladder cancer or completed their last
intravesical therapy >6 months before screening.
6. 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).
7. Patient has a predicted life expectancy of =3 months.
8. 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).
9. 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.
10. 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.
11. 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.
12. 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:
1. 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.
2. 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.
13. Patient is willing and able to participate in the study and comply with all study
requirements.
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not to be enrolled in this
study.
1. Patients received prior intravesical therapy for bladder cancer within =6 months of
the current diagnosis.
2. Patients must not have had any of the following within 6 months before study drug
administration:
1. Myocardial infarction
2. Severe/unstable angina
3. Symptomatic congestive heart failure
4. Cerebrovascular accident or transient ischemic attack, or
5. Pulmonary embolism
3. Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology
Criteria for Adverse Events (CTCAE) Version 4.03 grade 2.
4. Evidence of New York Heart Association (NYHA) functional class III or IV heart
disease.
5. Uncontrolled hypertension (>150/100 mmHg despite optimal medical therapy).
6. 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.
7. 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.
8. If female, patient is pregnant or breast-feeding.
9. Patient has evidence of a serious active infection (e.g., infection requiring
treatment with IV antibiotics).
10. Patient has a known, active Hepatitis A infection.
11. 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.
12. 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.
13. Patient is taking warfarin.
14. 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:
1. Not currently active and diagnosed at least 3 years prior to the date of
registration.
2. Non-invasive diseases such as low risk cervical cancer or any cancer in situ.
3. 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.).
4. Non-muscle invasive bladder cancer (NMIBC) for which treatment was completed >6
months before the current diagnosis.
15. Patient has known allergy or hypersensitivity to any component of CPX-POM.
16. 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.
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