Status:
COMPLETED
Phase I Study of CPI-300 in Patients With Advanced Tumors
Lead Sponsor:
Coordination Pharmaceuticals, Inc.
Conditions:
Advanced Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 li...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04808453
Start Date
June 15 2021
End Date
December 15 2023
Last Update
February 7 2024
Active Locations (4)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
3
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203