Study of CPI-100 in Patients With Advanced Tumors
Completed · Phase 1
Conditions studied: Advanced Tumors
In brief
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 maximum tolerated dose (MTD).
Key facts
- Study ID
- NCT03781362
- Run by
- Coordination Pharmaceuticals, Inc.
- People needed
- 36
- Starts
- 2018-12-21
- Expected to finish
- 2022-06-21
- Last updated by the study team
- 2022-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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 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
Where it is running
- South Texas Accelerated Research Therapeutics — Grand Rapids, Michigan, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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