Clinical Trials /

Study of CPI-100 in Patients With Advanced Tumors

NCT03781362

Description:

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).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of CPI-100 in Patients With Advanced Tumors
  • Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CPI-CL18-001
  • NCT ID: NCT03781362

Conditions

  • Advanced Tumors

Interventions

DrugSynonymsArms
CPI-100CPI-100 Combination with Capecitabine
CapecitabineCPI-100 Combination with Capecitabine

Purpose

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).

Detailed Description

      Primary Objectives:

      • To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-100 as once
      every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced
      tumors

      Secondary Objectives:

        -  To evaluate the pharmacokinetics (PK) of CPI-100

        -  To evaluate clinical response and resolution of symptoms after CPI-100 treatment

        -  To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with
           capecitabine in patients with advanced cancers

      Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W
      Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm
      B) will be tested in a dose escalation study. 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-100 within 28 days (Q2W) or 42 days (Q3W):

        -  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)
    

Trial Arms

NameTypeDescriptionInterventions
CPI-100 MonotherapyExperimentalDose Escalation Groups: CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group
  • CPI-100
CPI-100 Combination with CapecitabineExperimentalCPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)
  • CPI-100
  • Capecitabine

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

          -  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
      
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:28 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 CTCAE5

Secondary Outcome Measures

Measure: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 (%)
Measure: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
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:8 Days
Safety Issue:
Description:• To evaluate maximum plasma concentration (Cmax) of CPI-100 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-100 in patients tested

Details

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

Trial Keywords

  • Intravenous infusion

Last Updated

January 24, 2020