Advanced Tumors
Conditions
Keywords
Intravenous Infusion
Brief summary
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).
Detailed description
Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days: * Grade 4 or greater treatment related adverse events * Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours) Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment.
Interventions
DRUGCPI-300
CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
Sponsors
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
accelerated titration method followed by a conventional 3 + 3 dose escalation study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 (%) |
Countries
United States
Outcome results
None listed