Advanced Tumors
Conditions
Keywords
Intravenous infusion
Brief summary
This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 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-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors Secondary Objectives: * To evaluate the pharmacokinetics (PK) of CPI-100 * To evaluate clinical response and resolution of symptoms after CPI-100 treatment * To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. 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-100 within 28 days (Q2W) or 42 days (Q3W): * 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)
Interventions
DRUGCPI-100
CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
DRUGCapecitabine
Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period
Sponsors
Coordination Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 * 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 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 * Is pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | 28 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 CTCAE5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| 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 |
| Maximum Plasma Concentration (Cmax) | 8 Days | • To evaluate maximum plasma concentration (Cmax) of CPI-100 in patients tested |
| Area Under the Curve (AUC) | 8 Days | • To evaluate area under the curve (AUC) of CPI-100 in patients tested |
Countries
United States
Outcome results
None listed