Registry Study for Personalized Cancer Therapy



Status:Recruiting
Conditions:Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2015
Contact:Funda Meric-Bernstam, MD
Phone:713-745-4453

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The goal of this registry study is create a database to learn if using FDA-approved and
commercially available therapies off-label (meaning that the drugs are used for purposes
other than what they were approved for) can help to control the disease in patients who have
known genomic mutations in cancer-related genes. Registry studies only collect information
from you, such as the results of treatment and other information found in your medical
record.

Researchers want to use this registry to help doctors and patients match types of genomic
mutations to off-label uses of FDA approved therapies.

Study Treatment Assignment:

If you are found to be eligible to take part in this study, the study doctor will review the
test results in your medical records that were previously performed as part of your routine
care. The results of the testing may be helpful in managing your treatment and may also help
the doctor to find effective off-label use of FDA approved therapies for the type of cancer
you have.

After reviewing the screening tests and the molecular test results in your medical records,
the study staff and your study doctor will work together to find an off-label use for an FDA
approved therapy that is best for you. You may receive a single therapy or a combination of
therapies. You and the study doctor will discuss this.

The study doctor or study staff will tell you which drug(s) you will be taking, the dose of
the study drug(s), and how often you should take them. You will sign a separate consent form
that explains in more detail how the study drug(s) are administered and the potential
benefits and side effects of taking the study drug(s).

While you are receiving treatment, you will continue to have your routine, standard of care
clinic visits and routine tests so that the doctor may check the status of the disease to
learn if the therapy chosen to treat the disease is having any effect. Information from
these routine visits will be collected and stored by the study staff. If you agree, an
additional blood and urine sample will be collected to look for changes in your DNA at each
standard of care clinic visits during and at the end of your treatment.

This is an investigational study.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. 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.

2. Patients with a potentially actionable genomic alteration.

3. All prior treatment-related toxicities must be resolved to CTCAE (Version 4.0) < or =
Grade 2 (except alopecia) at the time of screening.

4. Patients willing to sign informed consent.

5. Patients > or = 18 years old.

6. 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.

Exclusion Criteria:

1. 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.

2. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to planned treatment drug.

3. Rapidly progressing leptomeningeal or brain metastases or spinal cord compression.

4. Clinical trial (including targeted and/or non-targeted) other than registry study is
available; patient is willing and eligible to enroll in such trial.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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