IMPACT 2: Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT02152254|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2014
Last Update Posted : January 25, 2018
You are being asked to take part in this study because you have metastatic cancer (cancer that has spread to other parts of the body).
Cancer can be caused by abnormalities in genetic material (such as gene mutations). These genetic differences can be found by studying the tumor (molecular profiling). Information from molecular profiling can be used to choose treatment that may target the tumor. This is known as personalized medicine. Early studies have shown that molecular profiling has led to patients being treated with more specialized therapy than they would normally receive. At this time is it unknown whether molecular profiling and selection of treatment has different results than standard-of-care treatment.
The goal of this research study is to compare the effects of treatment based on molecular profiling to those of the standard-of-care.
This is an investigational study.
Up to 1,362 participants will take part in this study. All will be enrolled at MD Anderson and its regional care centers.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: Targeted Therapy Based on Molecular Profiling Drug: Standard-of-Care Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||391 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT 2)|
|Actual Study Start Date :||May 13, 2014|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Active Comparator: Arm A: Targeted Therapy
Personalized treatment, targeted therapy against the alteration based on molecular profiling.
Drug: Targeted Therapy Based on Molecular Profiling
Patients randomized to receive targeted therapy will participate in clinical trials, and will be treated at the expansion phase of Phase I clinical trials or in Phase II clinical trials. If a clinical trial is not available and a commercially available targeted therapy exists (FDA-approved for another indication), patients may receive the FDA-approved drug.
Experimental: Arm B: Standard-of-Care Therapy
Standard-of-Care treatment not selected on basis of alteration analysis.
Drug: Standard-of-Care Therapy
Standard-of-care treatment regimen will be left to the discretion of the treating physician.
- Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms [ Time Frame: Continuous Monitoring, expected range from 2 months to 3 years ]Progression-free survival (PFS) of patients treated with a targeted therapy selected on the basis of mutational analysis of the tumor compared with PFS of those whose treatment is not selected based on alteration analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152254
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Apostolia M. Tsimberidou, MD, PHD||M.D. Anderson Cancer Center|