Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Drug: Therapeutic Intervention

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).

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rachel Miller, MD; Phone Number: 859-323-2196; Email: raware00@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • Markey Cancer Center, University of Kentucky
      • Contact: Rachel Miller, MD; Phone Number: 859-323-2196; Email: raware00@uky.edu
      • Principal Investigator: Rachel Miller, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapeutic Intervention	Drug: Therapeutic Intervention; Therapeutic Intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rachel Miller
• Investigators: Principal Investigator: RACHEL MILLER, MD, University of Kentucky

Publications and helpful links

General Publications

• Miller RW, Hutchcraft ML, Weiss HL, Wu J, Wang C, Liu J, Jayswal R, Buchanan M, Anderson A, Allison DB, El Khouli RH, Patel RA, Villano JL, Arnold SM, Kolesar JM. Molecular Tumor Board-Assisted Care in an Advanced Cancer Population: Results of a Phase II Clinical Trial. JCO Precis Oncol. 2022 Aug;6:e2100524. doi: 10.1200/PO.21.00524.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2017
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCC-16-MULTI-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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