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

NCT ID: NCT04808453

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2023-12-15

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.

Conditions

Advanced Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CPI-300

Intervention Type: DRUG

CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Interventions

CPI-300

CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordination Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Honor Health Research Institute

Scottsdale, Arizona, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

CPI-300CL21-01

Identifier Type: -

Identifier Source: org_study_id