Study of CPI-100 in Patients With Advanced Tumors

• Status: Recruiting
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: All

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 maximum tolerated dose (MTD).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordination Pharmaceuticals, Inc.
• Treatments: Capecitabine

Criteria

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

• 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 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