Recruiting
Phase 2

Targeted Therapy

Sponsor:

Rachel Miller

Code:

NCT03089554

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Therapeutic Intervention

Study Details

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

Study ID

NCT03089554

Start date

Apr 11, 2017

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

93 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Therapeutic Intervention

Therapeutic Intervention

Interventions

Therapeutic Intervention

Therapeutic Intervention

Primary outcome measure

  • Progression Free Survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

RACHEL MILLER, MD

859-323-2196raware00@uky.edu

Locations

Markey Cancer Center, University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Rachel Miller, MD

859-323-2196raware00@uky.edu

Principal Investigator:

Rachel Miller, M.D.

More Information

Sponsor

Rachel Miller

Last update posted

May 27, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rachel Miller on 2026-05-27.