Clinical Trials /

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

NCT04808453

Description:

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).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study of CPI-300 in Patients With Advanced Tumors
  • Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CPI-300CL21-01
  • NCT ID: NCT04808453

Conditions

  • Advanced Tumors

Interventions

DrugSynonymsArms
CPI-300CPI-300

Purpose

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).

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 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.
    

Trial Arms

NameTypeDescriptionInterventions
CPI-300ExperimentalDose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
  • CPI-300

Eligibility 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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety
Time Frame:28 days
Safety Issue:
Description:To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%

Secondary Outcome Measures

Measure:Clinical Benefit
Time Frame:28 Days and additional CPI-300 treatments till disease progression or intolerability
Safety Issue:
Description:To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Measure:Adverse Effect
Time Frame:28 Days and additional CPI-300 treatment till disease progression or intolerability
Safety Issue:
Description:To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:8 Days
Safety Issue:
Description:To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested
Measure:Area Under the Curve (AUC)
Time Frame:8 Days
Safety Issue:
Description:To evaluate area under the curve (AUC) of CPI-300 in patients tested

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Coordination Pharmaceuticals, Inc.

Trial Keywords

  • Intravenous Infusion

Last Updated

August 2, 2021