Registry Study for Personalized Cancer Therapy

Completed

Conditions studied: Advanced Cancers, Solid Tumors

In brief

Objectives: Primary Objectives: To evaluate the anti-cancer activity of commercially available, targeted anti-cancer therapies used off-label for treatment in patients with advanced solid cancer with known genomic aberrations. Secondary Objectives: To determine outcomes of patients who were treated with matched targeted anti-cancer therapies based on known genomic aberrations. To obtain treatment related adverse events in patients with advanced solid tumor who were treated with off -label targeted therapies. To determine co-genomic aberrations that may contribute to treatment response or resistance mechanisms. To determine feasibility of detecting the genomic alterations in plasma, and the genomic evolution of circulating biomarkers.

Key facts

Study ID

NCT02508662

Run by

M.D. Anderson Cancer Center

People needed

5

Starts

2015-07-21

Expected to finish

2020-07-10

Last updated by the study team

2020-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced or metastatic cancer that is refractory to standard therapy or that has relapsed after standard therapy or has no standard therapy that increases survival by at least three months.
• Patients with a potentially actionable genomic alteration.
• All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or = Grade 2 (except alopecia) at the time of screening.
• Patients willing to sign informed consent.
• Patients under the age of 18 years old are allowed as long as the safety profile of the drug is established in the pediatric population.

You may not qualify if…

• Any serious and/or unstable pre-existing medical disorder, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.
• Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to planned treatment drug.
• Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.
• Clinical trial (including targeted and/or non-targeted) other than registry study is available; patient is willing and eligible to enroll in such trial.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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