NCT02272595

Rational Therapeutics Based on Matched Tumor and Normal Tissue

A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this laboratory research study is to learn if using molecular information (matched therapy) or not using molecular information and having the study doctor choose the therapy based on your past experience are more effective ways to choose the best cancer treatment for you. This is an investigational study. Up to 200 participants will take part in this study. Up to 50 will be enrolled at MD Anderson.

Detailed description

If you agree to take part in this study, your tumor tissue and blood samples will be tested for molecular profiling. Molecular profiling is the classification of tissue based on the expression of certain genes within a tumor compared to normal tissue. This may be used to predict how the tumor responds to therapy. Your doctor may use the results of the molecular profiling to help decide which treatment might be the most beneficial for the disease. Study Procedures: Blood (about 2 teaspoons) will be drawn and you will have a tumor biopsy and a biopsy of normal tissue when you enroll in this study. Blood (about 2 teaspoons) will be drawn again about 2-3 weeks after you begin treatment. The type of biopsy you have will depend on the type of disease you have. The risks of this procedure will be discussed in more detail with you. If there is not enough tissue with which the study doctor can perform the study tests (described below), you may need to have a second biopsy. The study staff will discuss this with you if it is needed. Treatment Arms: A series of tests to find which gene mutations you have, if any, will be performed. Depending on the results of your molecular testing, you may be enrolled on 1 of 2 arms. If your molecular profile shows that you have a gene mutation that may benefit from study drugs that are believed to target your gene mutation, you will be enrolled in Arm A and will receive these targeted drugs. If your molecular profile shows that you do not have a gene mutation, you will be enrolled in Arm B. In Arm B, the doctor will choose a therapy based on other studies rather than gene mutation. Length of Study: This study will last about 2 years. Your participation on this study will be complete after the last blood draw and tumor biopsy is collected.

Conditions

• Advanced Cancers

Interventions

Type	Name	Description
OTHER	Treatment Based on Genetic Mutation	Participant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs.
OTHER	Treatment Based on No Genetic Mutation	Participant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation.

Timeline

• Start date: 2014-11-04
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2014-10-23
• Last updated: 2022-02-15

Locations

4 sites across 4 countries: United States, France, Israel, Spain