Status:
COMPLETED
Study of CPI-100 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, 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 max...
Detailed Description
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 advanc...
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
- 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 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
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03781362
Start Date
December 21 2018
End Date
June 21 2022
Last Update
July 20 2022
Active Locations (3)
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1
South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, United States, 49546
2
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
3
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229