Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

NCT03089554 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-16-MULTI-19
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Proportion of patients achieving a PFS ratio ≥1.3.

  2 years

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Therapeutic Intervention

Drug: Therapeutic Intervention

Interventions

Therapeutic Intervention DRUG

Therapeutic Intervention

Therapeutic Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rachel Miller: lead

Study Sites (1)

Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36103643 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Therapeutics

Study Officials

• RACHEL MILLER, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RACHEL MILLER, MD

CONTACT

859-323-2196; raware00@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 24, 2017
• Study Start: April 11, 2017
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)