Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT03348514 |
Recruitment Status :
Recruiting
First Posted : November 21, 2017
Last Update Posted : February 5, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Solid Tumors | Drug: CPX-POM | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
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. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors |
Actual Study Start Date : | January 15, 2018 |
Estimated Primary Completion Date : | July 31, 2019 |
Estimated Study Completion Date : | July 31, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Accelerated Escalation Design |
Drug: CPX-POM
CPX-POM |
Experimental: "3+3" Dose Escalation Design |
Drug: CPX-POM
CPX-POM |
- Evaluate the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD)of CPX-POM [ Time Frame: 21 days ]
The primary objective of this study is to evaluate the dose limiting toxicities (DLTs) and maximum tolerated dose (MTD) 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 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.
The MTD is defined as the dose BELOW that dose which causes DLTs in ≥33% of patients.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria Include:
- Patient has histologically- or cytologically- confirmed metastatic or advanced-stage solid malignant tumor that is refractory to standard therapy. Patients should only be included if no therapy exists or if they have already received all standard therapies that would be potentially curative or might provide significant benefit.
- Patient may have received up to 4 prior lines of cytotoxic chemotherapy or immunotherapy for their metastatic disease (e.g., docetaxel + doxorubicin ± cyclophosphamide), and also may have received additional prior endocrine therapy, as appropriate (e.g., for breast or prostate cancer), or non-myelosuppressive therapy (e.g., bevacizumab, trastuzumab).
- Patient has experienced progressive disease during or following or was intolerant of their most recent treatment regimen. Supporting information about prior progressive disease will be collected, if available.
- Patient is male or female aged ≥18 years.
- Patient provided signed and dated informed consent prior to initiation of any study procedures.
- 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), as assessed on Composite International Diagnostic Interview (CIDI), before the first dose of CPX-POM.
- Patient has adequate renal function (creatinine ≤1.5 × the upper limit of normal [ULN]) or a glomerular filtration rate (GFR) of ≥50 mL/min).
- 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.
- 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 ≥100×109cells/L, and absolute neutrophil count (ANC) ≥1.5×109 cells/L.
- Patient has no significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of CPX-POM. 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.
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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 CIDI 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.
Exclusion Criteria Include:
Patients who meet any of the following exclusion criteria are not to be enrolled in this study
- Patient has a history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or requires the use of concomitant medications that prolong the QT/QTc interval during study participation (refer to the following for examples: http://www.azcert.org/medical-pros/drug-lists/drug-lists.cfm).
- Patient has an abnormal cardiac appearance/heart size, as evidenced by chest X-ray or computed tomography (CT) scan.
- Patient has an uncontrolled or severe intercurrent medical condition.
- Patient underwent major surgery within 4 weeks before the first dose of CPX-POM or received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) or an investigational drug or device within 4 weeks (6 weeks for mitomycin C and nitrosoureas) 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. In addition, any drug-related toxicity, with the exception of alopecia, should have recovered to ≤Grade 1.
- If female, patient is pregnant or breast-feeding.
- Patient has evidence of a serious active infection (e.g., infection requiring treatment with intravenous antibiotics).
- 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.
- Patient has a history of other malignancy treated with curative intent within the previous 5 years with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous invasive cancers are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348514
United States, Colorado | |
Sarah Cannon Research Institute | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Kari Koga 720-754-4650 kari.koga@sarahcannon.com | |
Contact: Kelly Mozzetta 720-754-4646 kelly.mozetta@sarahcannon.com | |
Principal Investigator: Gerald Falchook | |
United States, Florida | |
Florida Cancer Specialists & Research Institute | Recruiting |
Sarasota, Florida, United States, 34232 | |
Contact: Michele LaRoc 941-377-9993 Mlaroc@flcancer.com | |
Contact: Heather Reith 941-377-9993 Hreith@flcancer.com | |
Principal Investigator: Manish Patel | |
United States, Oklahoma | |
Stephenson Cancer Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Julia Neuenschwander 405-271-8001 ext 48536 Julia-Neuenschwander@ouhsc.edu | |
Contact: Natashia Moreno (405)271-8001 ext 48394 Natashia-Moreno@ouhsc.edu | |
Principal Investigator: Susanna Ulahannan | |
United States, Tennessee | |
Tennessee Oncology PLLC | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Rachell Bellamy 615-341-7851 Rachell.Bellamy@sarahcannon.com | |
Principal Investigator: Howard Burris |
Responsible Party: | CicloMed LLC |
ClinicalTrials.gov Identifier: | NCT03348514 History of Changes |
Other Study ID Numbers: |
CPX-POM-01-001 |
First Posted: | November 21, 2017 Key Record Dates |
Last Update Posted: | February 5, 2019 |
Last Verified: | February 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |