Advanced Solid Tumors
Conditions
Brief summary
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type.
Detailed description
The study will initially employ an accelerated escalation design, with a single patient enrolled in each cohort (i.e., Single-Patient Cohorts). The initial patient will receive CPX-POM at a starting dose of 30 mg/m2. Doses will be escalated (doubling), until a ≥Grade 2 toxicity (with the exception of alopecia), is encountered. Subsequently that and all subsequent cohorts will follow a classical 3+3 dose escalation design. Note: Fosciclopirox is the generic name for CPX-POM.
Interventions
DRUGCPX-POM - 30 mg/m^2
CPX-POM
DRUGCPX-POM - 60 mg/m^2
CPX-POM
DRUGCPX-POM - 120 mg/m^2
CPX-POM
DRUGCPX-POM - 240 mg/m^2
CPX-POM
DRUGCPX-POM - 360 mg/m^2
CPX-POM
DRUGCPX-POM - 600 mg/m^2
CPX-POM
DRUGCPX-POM - 900 mg/m^2
CPX-POM
DRUGCPX-POM - 1200 mg/m^2
CPX-POM
Sponsors
Cmed Clinical Services
CicloMed LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a Phase I, first-in-human, multicenter, open label, dose escalating study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Include: 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 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). 4. Patient has a predicted life expectancy of ≥3 months. 5. Dose escalation cohorts only: Patient has adequate renal function (creatinine ≤1.5 × the upper limit of normal \[ULN\]) or a glomerular filtration rate (GFR) of ≥50 mL/min/1.73 m\^2). Expansion cohort only: Patient has a GFR of ≥30 mL/min/1.73 m\^2. 6. Patient has adequate hepatic function, as evidenced by a total bilirubin ≤1.5 × ULN, aspartate transaminase (AST), and /or alanine transaminase (ALT) ≤3 × ULN or ≤5 ×ULN, if due to liver involvement by tumor. 7. 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. 8. Patient has no significant ischemic heart disease or myocardial infarction (MI) 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 (QTc) \<470 msec by Fridericia (QTcF). 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. 9. 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. 10. Patient is willing and able to participate in the study and comply with all study requirements.
Exclusion criteria
Include: Patients who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Up to 22 days for each cohort | The primary objective of this study is to evaluate the dose limiting toxicities (DLTs) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. A DLT will include some Grade 3 or 4 AEs (as assessed by CTCAE version 4.03) 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. In order to identify any DLTs, safety assessments including AEs, physical examinations, vital signs, and clinical laboratory tests will be conducted during each study visit through Day 22. |
| Determine the Maximum Tolerated Dose (MTD) of CPX-POM | Days 1, 2, 3, 4, 5, 6, 10, 22 and 28 | The primary objective of this study is to evaluate the maximum tolerated dose (MTD) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. MTD was determined by testing increasing doses up to 1200 mg/m\^2 by IV. The MTD is defined as the dose BELOW that dose which causes DLTs in ≥33% of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure PK parameter area-under-the-plasma-drug/metabolite-concentration-time curve (ng/mL/hr) following single dose (AUC) and at steady-state AUCss following single and repeat drug administration. |
| Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure PK parameter Cls (mL/hr/kg) - systemic clearance following single dose (Cls) following single and repeat drug administration. |
| Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure PK parameters Vd (apparent volume of distribution) and Vss (steady state volume of distribution) (mL/kg) |
| Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure PK parameter Cmax (ng/mL) |
| Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure Percent Dose (%) |
| Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Measure urine CPX concentration (uM) |
| Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Determine PK parameter AUC derived accumulation ratio (AUCss/AUCi ratio) |
| Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Days 5-6 | Determine Terminal Half-Life |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPX-POM - 30 mg/m^2 Period1, Dose Cohort - 30 mg/m\^2 | 1 |
| CPX-POM - 60 mg/m^2 Period 2, Dose Cohort - 60 mg/m\^2 | 1 |
| CPX-POM - 120 mg/m^2 Period 3, Dose Cohort - 120 mg/m\^2 | 1 |
| CPX-POM - 240 mg/m^2 Period 4, Dose Cohort - 240 mg/m\^2 | 1 |
| CPX-POM - 360 mg/m^2 Period 5, Dose Cohort - 360 mg/m\^2 | 3 |
| CPX-POM - 600 mg/m^2 Period 6, Dose Cohort - 600 mg/m\^2 | 4 |
| CPX-POM - 900 mg/m^2 Period 7, Dose Cohort - 900 mg/m\^2 | 6 |
| CPX-POM - 1200 mg/m^2 Period 8, Dose Cohort - 1200 mg/m\^2 | 2 |
| Total | 19 |
Baseline characteristics
| Characteristic | CPX-POM - 60 mg/m^2 | CPX-POM - 120 mg/m^2 | CPX-POM - 240 mg/m^2 | CPX-POM - 360 mg/m^2 | CPX-POM - 600 mg/m^2 | CPX-POM - 900 mg/m^2 | CPX-POM - 30 mg/m^2 | CPX-POM - 1200 mg/m^2 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62 years | 76 years | 61 years | 54 years | 63 years | 60 years | 46 years | 82.5 years | 63 years |
| Cancer type Bladder | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Cancer type Breast | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Cancer type Colon | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 5 Participants |
| Cancer type Gastric | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Cancer type Head and Neck | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer type Liver | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer type Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants |
| Cancer type Ovarian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer type Prostate | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 5 Participants | 1 Participants | 2 Participants | 18 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 4 Participants | 0 Participants | 0 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 4 | 0 / 6 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 1 / 1 | 1 / 1 | 1 / 3 | 3 / 4 | 6 / 6 | 1 / 2 |
| serious Total, serious adverse events | 1 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 1 / 3 | 3 / 4 | 1 / 6 | 1 / 2 |
Outcome results
Primary
Determine the Maximum Tolerated Dose (MTD) of CPX-POM
The primary objective of this study is to evaluate the maximum tolerated dose (MTD) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. MTD was determined by testing increasing doses up to 1200 mg/m\^2 by IV. The MTD is defined as the dose BELOW that dose which causes DLTs in ≥33% of patients.
Time frame: Days 1, 2, 3, 4, 5, 6, 10, 22 and 28
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPX-POM - 30 mg/m^2 | Determine the Maximum Tolerated Dose (MTD) of CPX-POM | 900 mg/m^2 |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM
The primary objective of this study is to evaluate the dose limiting toxicities (DLTs) of ciclopirox phosphoryloxymethyl ester (CPX-POM) administered intravenously (IV) and establish the CPX POM dose recommended for further investigation. A DLT will include some Grade 3 or 4 AEs (as assessed by CTCAE version 4.03) 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. In order to identify any DLTs, safety assessments including AEs, physical examinations, vital signs, and clinical laboratory tests will be conducted during each study visit through Day 22.
Time frame: Up to 22 days for each cohort
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 30 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
| CPX-POM - 60 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 60 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
| CPX-POM - 120 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 120 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
| CPX-POM - 240 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 240 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
| CPX-POM - 360 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 360 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
| CPX-POM - 600 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 600 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 2 participants |
| CPX-POM - 900 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 2 participants |
| CPX-POM - 900 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 0 participants |
| CPX-POM - 1200 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 3 | 1 participants |
| CPX-POM - 1200 mg/m^2 | Number of Participants With Dose Limiting Toxicities (DLTs) of CPX-POM | Grade 1 | 0 participants |
Secondary
Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Measure PK parameter area-under-the-plasma-drug/metabolite-concentration-time curve (ng/mL/hr) following single dose (AUC) and at steady-state AUCss following single and repeat drug administration.
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 589 ng*hr/mL | — |
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 515 ng*hr/mL | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 1262 ng*hr/mL | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 1328 ng*hr/mL | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 3736 ng*hr/mL | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 5143 ng*hr/mL | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 4622 ng*hr/mL | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 6000 ng*hr/mL | — |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 4731 ng*hr/mL | Standard Deviation 1310 |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 4856 ng*hr/mL | Standard Deviation 910 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 11914 ng*hr/mL | Standard Deviation 1852 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 12484 ng*hr/mL | Standard Deviation 1182 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 23414 ng*hr/mL | Standard Deviation 1913 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 24148 ng*hr/mL | Standard Deviation 6067 |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose AUCs | 34470 ng*hr/mL | — |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: AUCss (ng/mL/hr) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State AUCss | 28048 ng*hr/mL | — |
Secondary
Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Measure PK parameter Cls (mL/hr/kg) - systemic clearance following single dose (Cls) following single and repeat drug administration.
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 614 mL/hr/kg | — |
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 702 mL/hr/kg | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 581 mL/hr/kg | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 552 mL/hr/kg | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 361 mL/hr/kg | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 262 mL/hr/kg | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 515 mL/hr/kg | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 397 mL/hr/kg | — |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 1065 mL/hr/kg | Standard Deviation 435 |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 963 mL/hr/kg | Standard Deviation 271 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 507 mL/hr/kg | Standard Deviation 95 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 471 mL/hr/kg | Standard Deviation 113 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 421 mL/hr/kg | Standard Deviation 184 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 432 mL/hr/kg | Standard Deviation 142 |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Single Dose Cls | 375 mL/hr/kg | — |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Cls (mL/hr/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Steady State Cls | 456 mL/hr/kg | — |
Secondary
Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Measure PK parameter Cmax (ng/mL)
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 371 ng/mL | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1935 ng/mL | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 3491 ng/mL | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 6792 ng/mL | — |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 5297 ng/mL | Standard Deviation 1182 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 9457 ng/mL | Standard Deviation 512 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 17277 ng/mL | Standard Deviation 1913 |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Cmax (ng/mL) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 15970 ng/mL | — |
Secondary
Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Determine Terminal Half-Life
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 2.34 hours | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 0.54 hours | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 5.56 hours | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 3.34 hours | — |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 3.12 hours | Standard Deviation 1.34 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 4.61 hours | Standard Deviation 1.46 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 8.30 hours | Standard Deviation 2.63 |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Terminal Half-life of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 7.43 hours | — |
Secondary
Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Measure PK parameters Vd (apparent volume of distribution) and Vss (steady state volume of distribution) (mL/kg)
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 2053 mL/kg | — |
| CPX-POM - 30 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 2370 mL/kg | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 429 mL/kg | — |
| CPX-POM - 60 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 473 mL/kg | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 2100 mL/kg | — |
| CPX-POM - 120 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 1633 mL/kg | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 736 mL/kg | — |
| CPX-POM - 240 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 1966 mL/kg | — |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 1986 mL/kg | Standard Deviation 802 |
| CPX-POM - 360 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 4522 mL/kg | Standard Deviation 2715 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 3090 mL/kg | Standard Deviation 1015 |
| CPX-POM - 600 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 1346 mL/kg | Standard Deviation 349 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 5340 mL/kg | Standard Deviation 3935 |
| CPX-POM - 900 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 2261 mL/kg | Standard Deviation 1249 |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vd | 4887 mL/kg | — |
| CPX-POM - 1200 mg/m^2 | Assess Plasma PK: Vd and Vss (mL/kg) of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | Vss | 2518 mL/kg | — |
Secondary
Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Measure urine CPX concentration (uM)
Time frame: Days 5-6
Population: Urine pharmacokinetic data not obtained in one patient receiving 600 mg/m\^2 and one patient receiving 1200 mg/m\^2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 0.65 uM | — |
| CPX-POM - 60 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 0.84 uM | — |
| CPX-POM - 120 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 10.77 uM | — |
| CPX-POM - 240 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 3.93 uM | — |
| CPX-POM - 360 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 5.10 uM | Standard Deviation 0.86 |
| CPX-POM - 600 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 22.91 uM | Standard Deviation 12.83 |
| CPX-POM - 900 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 138.17 uM | Standard Deviation 157.97 |
| CPX-POM - 1200 mg/m^2 | Assess Urine PK: Average 24-hour Urine Concentration of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 208.65 uM | — |
Secondary
Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing.
Measure Percent Dose (%)
Time frame: Days 5-6
Population: Urine pharmacokinetic data not obtained in one patient receiving 600 mg/m\^2 and one patient receiving 1200 mg/m\^2
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 30 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 59.74 Percent of CPX-POM dose | — |
| CPX-POM - 30 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 0.81 Percent of CPX-POM dose | — |
| CPX-POM - 60 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 69.73 Percent of CPX-POM dose | — |
| CPX-POM - 60 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 0.82 Percent of CPX-POM dose | — |
| CPX-POM - 60 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 120 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 70.21 Percent of CPX-POM dose | — |
| CPX-POM - 120 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 120 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 1.74 Percent of CPX-POM dose | — |
| CPX-POM - 240 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 240 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 1.25 Percent of CPX-POM dose | — |
| CPX-POM - 240 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 73.86 Percent of CPX-POM dose | — |
| CPX-POM - 360 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 0.80 Percent of CPX-POM dose | Standard Deviation 0.21 |
| CPX-POM - 360 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 360 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 75.99 Percent of CPX-POM dose | Standard Deviation 10.4 |
| CPX-POM - 600 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 1.21 Percent of CPX-POM dose | Standard Deviation 0.11 |
| CPX-POM - 600 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 600 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 50.70 Percent of CPX-POM dose | Standard Deviation 29.28 |
| CPX-POM - 900 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 4.42 Percent of CPX-POM dose | Standard Deviation 4.68 |
| CPX-POM - 900 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 900 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 69.62 Percent of CPX-POM dose | Standard Deviation 15.16 |
| CPX-POM - 1200 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as CPX-POM over 24 hours | 0 Percent of CPX-POM dose | Standard Deviation 0 |
| CPX-POM - 1200 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox over 24 hours | 2.89 Percent of CPX-POM dose | — |
| CPX-POM - 1200 mg/m^2 | Assess Urine PK: Percent (%) of the CPX-POM Dose Excreted in Urine as CPX-POM and Metabolites, Following Five Consecutive Days of Once Daily Dosing. | % CPX-POM Dose Excreted as ciclopirox glucuronide over 24 hours | 68.19 Percent of CPX-POM dose | — |
Secondary
Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing.
Determine PK parameter AUC derived accumulation ratio (AUCss/AUCi ratio)
Time frame: Days 5-6
Population: Pharmacokinetic data not obtained in one patient receiving 1200 mg/m\^2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPX-POM - 30 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 0.86 ratio | — |
| CPX-POM - 60 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.05 ratio | — |
| CPX-POM - 120 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.59 ratio | — |
| CPX-POM - 240 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.30 ratio | — |
| CPX-POM - 360 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.08 ratio | Standard Deviation 0.14 |
| CPX-POM - 600 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.09 ratio | Standard Deviation 0.17 |
| CPX-POM - 900 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 1.03 ratio | Standard Deviation 0.29 |
| CPX-POM - 1200 mg/m^2 | Characterize Plasma PK: AUCss/AUCi Accumulation Ratio of the Active Metabolite, Ciclopirox (CPX), Following Five Consecutive Days of Once Daily Dosing. | 0.81 ratio | — |