Clinical Trials /

A Study of TRK-950 in Patients With Advanced Solid Tumors

NCT02990481

Description:

1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies

Related Conditions:
  • Bladder Carcinoma
  • Cholangiocarcinoma
  • Colon Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
  • Ovarian Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of TRK-950 in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of TRK-950 Given Intravenously on a Weekly x3 Followed by One Week Off Schedule in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: 950P1V01
  • NCT ID: NCT02990481

Conditions

  • Locally Advanced or Metastatic Solid Carcinomas

Interventions

DrugSynonymsArms
TRK-950TRK-950

Purpose

1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies

Detailed Description

      This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and
      is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated
      dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks
      every 28 days.
    

Trial Arms

NameTypeDescriptionInterventions
TRK-950Experimental

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Patients with histologically confirmed locally advanced or metastatic solid
                 carcinomas
    
              -  Tumor progression after receiving standard/approved chemotherapy or where there is no
                 approved therapy or not amendable to a curative treatment
    
              -  Measurable disease per RECIST 1.1 (primary or metastases)
    
            Exclusion Criteria:
    
              -  New York Heart Association Class III or IV, cardiac disease, myocardial infarction
                 within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
    
              -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
                 therapy
    
              -  Pregnant or nursing women
    
              -  Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy
                 within four weeks prior to study entry
    
              -  Unwillingness or inability to comply with procedures required in this protocol
    
              -  Known active infection with HIV, hepatitis B, hepatitis C
    
              -  Symptomatic brain metastases
    
              -  Serious nonmalignant disease that could compromise protocol objectives in the opinion
                 of the investigator and/or the sponsor
    
              -  Patients who are currently receiving any other investigational agent
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Adverse event
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Area under the concentration curve(AUC)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Maximum plasma concentration(Cmax)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Time to maximum plasma concentration(Tmax)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Terminal elimination half life(t1/2)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Total body clearance(CL)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Apparent volume of distribution(Vd)
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Tumor response rate
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Duration of response
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Time to progression
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:
    Measure:Progression free survival
    Time Frame:through study completion, an average of 1 year
    Safety Issue:
    Description:

    Details

    Phase:Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Toray Industries, Inc

    Last Updated

    February 27, 2017