NCT02152254

Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)

Randomized Study Evaluating Molecular Profiling and Targeted Agents in Metastatic Cancer: Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,362 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial studies how molecular profiling and targeted therapy work in treating patients with cancer that has spread to other places in the body compared to standard treatment. Information about genetic differences in a patient's tumor can be used to choose treatment that may target the tumor. It is not yet validated whether selecting treatment after studying the genetic changes that are associated with cancer in a patient's tumor is a better way to treat patients with metastatic cancer compared to therapy not based on studying the genetic changes that are associated with cancer.

Detailed description

I. To determine whether patients treated with a matched targeted therapy selected on the basis of genomic alteration analysis of the tumor have longer progression-free survival (PFS) than those whose treatment is not selected on the basis of alteration analysis. Genomic analysis of tumor sample will be performed at the time of enrollment to identify tumor molecular alterations and to assign treatment for every individual patient. OUTLINE: After completion of molecular profiling, patients who qualify for the trial will be offered randomization as previously. If they wish to be randomized, patients will be randomized to one of the two arms: matched targeted therapy (ARM I) or other therapy (ARM II). Patients who decline to be randomized will then be offered their choice of the two trial arms. ARM I: Matched targeted therapy: Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration \[FDA\]-approved for another indication), patients can receive the FDA-approved drug. ARM II: Other therapy: Patients receive standard of care therapy at the discretion of the treating physician. Patients with tumor progression who achieve the primary study endpoint can cross over to the other treatment arm.

Conditions

• Metastatic Malignant Neoplasm
• Recurrent Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Targeted Therapy Based on Molecular Profiling	Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration \[FDA\]-approved for another indication), patients can receive the FDA-approved drug.
DRUG	Standard-of-Care Therapy	Standard-of-care treatment regimen will be left to the discretion of the treating physician.

Timeline

• Start date: 2014-05-13
• Primary completion: 2030-12-31
• Completion: 2030-12-31
• First posted: 2014-06-02
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States