Clinical Trials /

Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

NCT03089554

Description:

This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB).

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
  • Official Title: Integration of Precision Medicine Into Cancer Therapeutics, Part 2: A Therapeutic Phase 2 Sub-study Evaluating Genomic Testing in Human Cancer and Outcomes of Targeted Therapies Recommended by an Institutional Multidisciplinary Molecular Tumor Board in Patients With Poor Prognosis Cancer

Clinical Trial IDs

  • ORG STUDY ID: MCC-16-MULTI-19
  • NCT ID: NCT03089554

Conditions

  • Cancer

Interventions

DrugSynonymsArms
Therapeutic InterventionTherapeutic Intervention

Purpose

This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB).

Detailed Description

      This prospective, single-arm trial in patients with refractory metastatic cancer will
      compare the Progression Free Survival (PFS) using a treatment regimen selected by the MCC
      MTB with the PFS (time to tumor progression) for the most recent regimen on which the
      patient had experienced progression (i.e., using patients as their own control).
    

Trial Arms

NameTypeDescriptionInterventions
Therapeutic InterventionExperimentalTherapeutic Intervention
  • Therapeutic Intervention

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with clinically suspected or histologically confirmed solid or hematological
             malignancy who have undergone or will undergo genetic testing of their tumor

          -  Patients must have failed first-line therapy for their disease (refractory) or have
             no options for curative therapies.

          -  Patients must have either measurable or non-measurable disease.

          -  Age ≥18 years.

          -  Eastern Cooperative Oncology Group performance status ≤3.

          -  Patients with brain metastasis must have had treatment of their brain metastasis
             completed at least 1 day prior to enrollment and be on stable dose of steroids or off
             steroids at the time of enrollment.

          -  Ability to understand and the willingness to sign a written informed consent
             document.

        Exclusion Criteria:

          -  Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to entering the study or those who have not
             recovered from adverse events due to agents administered more than 3 weeks earlier.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             targeted therapy, in the opinion of the treating physician.

          -  Pregnant women are excluded from this study.

          -  HIV positive patients with CD4 counts below 500 OR who are not on a stable dose of
             antiretroviral therapy (for at least 1 month prior to registration) are ineligible.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:2 years
Safety Issue:
Description:Proportion of patients achieving a PFS ratio ≥1.3.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Rachel Miller

Last Updated

March 17, 2017