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

Advanced Tumors Clinical Trial

— CPI-300  

Official title:

A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808453
• Other study ID #: CPI-300CL21-01
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2021
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Coordination Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Tumors

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Florida Cancer Specialists	Lake Mary	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Honor Health Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Coordination Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	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%	28 days
Secondary	Clinical Benefit	To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)	28 Days and additional CPI-300 treatments till disease progression or intolerability
Secondary	Adverse Effect	To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE	28 Days and additional CPI-300 treatment till disease progression or intolerability
Secondary	Maximum Plasma Concentration (Cmax)	To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested	8 Days
Secondary	Area Under the Curve (AUC)	To evaluate area under the curve (AUC) of CPI-300 in patients tested	8 Days