Evaluating Genomic Testing in Human Cancer & Outcomes of... | NCT03089554

Studies
Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

NCT03089554

Sponsor

Rachel Miller

Status

Recruiting

Last Update Posted

May 27, 2026Actual

Enrollment

93Estimated

Phase

Phase 2

Conditions

Cancer

Interventions

Therapeutic Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2017Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Mar 17, 2017

First Submission Date that Met QC Criteria

Mar 17, 2017

First Posted Date

Mar 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 27, 2026Actual

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Estimated

Label	Type	Description	Intervention Names
Therapeutic Intervention	Experimental	Therapeutic Intervention	Drug: Therapeutic Intervention

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Intervention	Drug	Therapeutic Intervention	Therapeutic Intervention

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
RACHEL MILLER, MD	Contact	859-323-2196		raware00@uky.edu

Name	Affiliation	Role
RACHEL MILLER, MD	University of Kentucky	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Markey Cancer Center, University of Kentucky	Recruiting	Lexington	Kentucky	40536	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36103643	Derived	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.