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

NCT04808453 | Completed Phase 1 FDA Drug

• 1 other identifier: CPI-300CL21-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

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).

Conditions

Advanced Tumors

Keywords

Intravenous Infusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical Benefit

  28 Days and additional CPI-300 treatments till disease progression or intolerability

• Adverse Effect

  28 Days and additional CPI-300 treatment till disease progression or intolerability

• Maximum Plasma Concentration (Cmax)

  8 Days

• Area Under the Curve (AUC)

  8 Days

Study Arms (1)

CPI-300

EXPERIMENTAL

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

Drug: CPI-300

Interventions

CPI-300 DRUG

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

CPI-300

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordination Pharmaceuticals, Inc.: lead

Study Sites (4)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

Florida Cancer Specialists

Lake Mary, Florida, 32746, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: accelerated titration method followed by a conventional 3 + 3 dose escalation study design

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: June 15, 2021
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)