NCT03089554 Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies
| NCT ID | NCT03089554 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rachel Miller |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 93 participants |
| Start Date | 2017-04-11 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 93 participants in total. It began in 2017-04-11 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
RACHEL MILLER, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT03089554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03089554 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03089554 currently recruiting?
Yes, NCT03089554 is actively recruiting participants. Contact the research team at raware00@uky.edu for enrollment information.
Where is the NCT03089554 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT03089554 clinical trial?
NCT03089554 is sponsored by Rachel Miller. The principal investigator is RACHEL MILLER, MD at University of Kentucky. The trial plans to enroll 93 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.