Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

NCT ID: NCT03089554

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-11
• Study Completion Date: 2026-04-30

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).

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).

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic Intervention

Therapeutic Intervention

Group Type: EXPERIMENTAL

Therapeutic Intervention

Intervention Type: DRUG

Therapeutic Intervention

Interventions

Therapeutic Intervention

Therapeutic Intervention

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rachel Miller

OTHER

Sponsor Role: lead

Responsible Party

Rachel Miller

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

RACHEL MILLER, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

RACHEL MILLER, MD

Role: CONTACT

raware00@uky.edu

859-323-2196

Facility Contacts

Rachel Miller, MD

Role: primary

raware00@uky.edu

859-323-2196

References

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.

Reference Type: DERIVED

PMID: 36103643 (View on PubMed)

Other Identifiers

MCC-16-MULTI-19

Identifier Type: -

Identifier Source: org_study_id