Phase I Study of CPI-300 in Patients With Advanced Tumors

Recruitment & Eligibility

Inclusion Criteria

Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
Have an ECOG performance status of 0-1
Have adequate bone marrow reserve, liver and renal function
Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

Exclusion Criteria

Have peripheral neuropathy of Grade 3 or Grade 4 at screening
Have peripheral sensory neuropathy of Grade 2 or greater at screening
Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
Have known hypersensitivity to chemotherapeutic agents
Have chronic diarrhea
Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe
Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment
Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
Is pregnant or breast-feeding

Study & Design

Arm && Interventions

Group	Intervention	Description
CPI-300	CPI-300	Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design

Primary Outcome Measures

Name	Time	Method
Adverse Events	28 days	To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%

Secondary Outcome Measures

Name	Time	Method
Adverse Effect	28 Days and additional CPI-300 treatment till disease progression or intolerability	To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Clinical Benefit	28 Days and additional CPI-300 treatments till disease progression or intolerability	To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Maximum Plasma Concentration (Cmax)	8 Days	To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested
Area Under the Curve (AUC)	8 Days	To evaluate area under the curve (AUC) of CPI-300 in patients tested

Trial Locations

Locations (4)

University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

Honor Health Research Institute

🇺🇸

Scottsdale, Arizona, United States

Sarah Cannon Research Institute

🇺🇸

Nashville, Tennessee, United States

Florida Cancer Specialists

🇺🇸

Lake Mary, Florida, United States

Recruitment & Eligibility