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Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089554
Recruitment Status : Recruiting
First Posted : March 24, 2017
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Rachel Miller, University of Kentucky

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Cancer Drug: Therapeutic Intervention Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: Therapeutic Intervention
Therapeutic Intervention
Drug: Therapeutic Intervention
Therapeutic Intervention




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years ]
    Proportion of patients achieving a PFS ratio ≥1.3.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089554


Contacts
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Contact: RACHEL MILLER, MD 859-323-2196 raware00@uky.edu

Locations
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United States, Kentucky
Markey Cancer Center, University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Rachel Miller, MD    859-323-2196    raware00@uky.edu   
Principal Investigator: Rachel Miller, M.D.         
Sponsors and Collaborators
Rachel Miller
Investigators
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Principal Investigator: RACHEL MILLER, MD University of Kentucky
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Responsible Party: Rachel Miller, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03089554    
Other Study ID Numbers: MCC-16-MULTI-19
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No