What this study is
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).
What's being tested
- Therapeutic Intervention
Intervention · DRUG
Therapeutic Intervention
Study details
- 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
- Sponsor
- Rachel Miller
- Conditions
- Cancer
- Enrolling
- 93 people
- Starts
- 2017-04-11
- Est. completion
- 2027-04
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMarkey Cancer Center, University of Kentucky
Lexington, Kentucky, United States
- Rachel Miller, MD · Contact859-323-2196raware00@uky.edu
- Rachel Miller, M.D. · Principal investigator
Recruiting
Study team
Sponsor
Rachel Miller
Study ID MCC-16-MULTI-19
Principal investigator
RACHEL MILLER, MD
University of Kentucky
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.