RecruitingPhase 2NCT03089554

Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

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

Enrollment

93 participants

Start Date

Apr 11, 2017

Study Type

INTERVENTIONAL

Conditions

Cancer

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria4

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.

Interested in this trial?

Get notified about updates and connect with the research team.