Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
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ClinicalTrials.gov Identifier: NCT03089554 |
Recruitment Status :
Recruiting
First Posted : March 24, 2017
Last Update Posted : February 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cancer | Drug: Therapeutic Intervention | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 93 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | April 11, 2017 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Therapeutic Intervention
Therapeutic Intervention
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Drug: Therapeutic Intervention
Therapeutic Intervention |
- Progression Free Survival [ Time Frame: 2 years ]Proportion of patients achieving a PFS ratio ≥1.3.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089554
Contact: RACHEL MILLER, MD | 859-323-2196 | raware00@uky.edu |
United States, Kentucky | |
Markey Cancer Center, University of Kentucky | Recruiting |
Lexington, Kentucky, United States, 40536 | |
Contact: Rachel Miller, MD 859-323-2196 raware00@uky.edu | |
Principal Investigator: Rachel Miller, M.D. |
Principal Investigator: | RACHEL MILLER, MD | University of Kentucky |
Responsible Party: | Rachel Miller, Principal Investigator, University of Kentucky |
ClinicalTrials.gov Identifier: | NCT03089554 |
Other Study ID Numbers: |
MCC-16-MULTI-19 |
First Posted: | March 24, 2017 Key Record Dates |
Last Update Posted: | February 25, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |