Advanced Solid Tumor
Conditions
Keywords
Intravenous infusion, Phase 1, CPI-200
Brief summary
This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 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
Primary Objectives: • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors Secondary Objectives: * To evaluate the pharmacokinetics (PK) of CPI-200 * To evaluate clinical response and resolution of symptoms after CPI-200 treatment * To characterize adverse events of CPI-200 in patients with advanced cancers Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days: * All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness * Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria * Grade 3 thrombocytopenia in the presence of bleeding * Grade 3 or greater febrile neutropenia * Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment
Interventions
DRUGCPI-200
CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle
Sponsors
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Accelerated titration method followed by a conventional 3 + 3 study design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Males and females * 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 a life expectancy of at least 12 weeks (in the opinion of the investigator) * Have adequate bone marrow reserve, liver and renal function * Be reasonably recovered from preceding major surgery and 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 3 months after the last day of treatment
Exclusion criteria
* Have peripheral sensory neuropathy of Grade 2 or greater at screening * Have known hypersensitivity to chemotherapeutic agents * Have 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: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40% * 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 |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 21 days | • To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinical Benefit | through study completion, an average of 4 months | • To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants |
| Rate of Adverse Effect | through study completion, an average of 4 months | • To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants |
| Maximum Plasma Concentration (Cmax) | 8 Days | • To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested |
| Area Under the Curve (AUC) | 8 Days | • To evaluate area under the curve (AUC) of CPI-200 in patients tested |
Countries
United States
Outcome results
None listed