Study of CPI-100 in Patients With Advanced Tumors

Coordination Pharmaceuticals, Inc.36 enrolled

Overview

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).

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)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Tumors

Interventions

CPI-100DRUG

CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

CapecitabineDRUG

Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

South Texas Accelerated Research Therapeutics

Grand Rapids, Michigan, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Maximum Tolerated Dose (MTD)

• 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

Time frame: 28 Days

Secondary Outcomes

Clinical Benefit

• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)

Time frame: through study completion, an average of 4 months

Adverse Effect

• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE

Time frame: through study completion, an average of 4 months

Maximum Plasma Concentration (Cmax)

• To evaluate maximum plasma concentration (Cmax) of CPI-100 in patients tested

Time frame: 8 Days

Area Under the Curve (AUC)

• To evaluate area under the curve (AUC) of CPI-100 in patients tested

Time frame: 8 Days

Data from ClinicalTrials.gov

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