Clinical Trials /

Study of CPI-200 in Patients With Advanced Tumors

NCT03953742

Description:

This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 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: Study of CPI-200 in Patients With Advanced Tumors
  • Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CPI-200CL01
  • NCT ID: NCT03953742

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
CPI-200CPI-200

Purpose

This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 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

      Primary Objectives:

      • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in
      patients with advanced tumors

      Secondary Objectives:

        -  To evaluate the pharmacokinetics (PK) of CPI-200

        -  To evaluate clinical response and resolution of symptoms after CPI-200 treatment

        -  To characterize adverse events of CPI-200 in patients with advanced cancers

      Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed
      by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:

        -  All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding
           toxicities clearly related to disease progression or inter-current illness

        -  Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of
           Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3
           fatigue if lasting less than 7 days as determined by CTCAEv5 criteria

        -  Grade 3 thrombocytopenia in the presence of bleeding

        -  Grade 3 or greater febrile neutropenia

        -  Any hematologic or non-hematologic adverse events or abnormal laboratory value(s)
           related to CPI-200 that result(s) in permanent study discontinuation of study treatment
    

Trial Arms

NameTypeDescriptionInterventions
CPI-200ExperimentalDose Escalation Group: CPI-200 will be administered via intravenous infusion once every 3 weeks for up to 7 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
  • CPI-200

Eligibility Criteria

        Inclusion Criteria:

          -  Age >18 years

          -  Males and females

          -  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 a life expectancy of at least 12 weeks (in the opinion of the investigator)

          -  Have adequate bone marrow reserve, liver and renal function

          -  Be reasonably recovered from preceding major surgery and 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 3 months after the last day of treatment

        Exclusion Criteria:

          -  Have peripheral sensory neuropathy of Grade 2 or greater at screening

          -  Have known hypersensitivity to chemotherapeutic agents

          -  Have 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:
             unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic
             attack, cardiac failure with known ejection fraction less than 40%

          -  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:Maximum Tolerated Dose (MTD)
Time Frame:21 days
Safety Issue:
Description:• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE

Secondary Outcome Measures

Measure:Rate of Clinical Benefit
Time Frame:through study completion, an average of 4 months
Safety Issue:
Description:• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants
Measure:Rate of Adverse Effect
Time Frame:through study completion, an average of 4 months
Safety Issue:
Description:• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:8 Days
Safety Issue:
Description:• To evaluate maximum plasma concentration (Cmax) of CPI-200 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-200 in patients tested

Details

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

Trial Keywords

  • Intravenous infusion
  • Phase 1
  • CPI-200

Last Updated

July 3, 2019