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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2022
  • participants needed
    17
  • sponsor
    Coordination Pharmaceuticals, Inc.
Updated on 26 July 2022

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).

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 limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days:

  • Grade 4 or greater treatment related adverse events
  • Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)

Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment.

Details
Condition Advanced Tumors
Treatment CPI-300
Clinical Study IdentifierNCT04808453
SponsorCoordination Pharmaceuticals, Inc.
Last Modified on26 July 2022

Eligibility

Yes No Not Sure

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
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 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 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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