A Phase II Randomized Study Evaluating Molecular Profiling and Targeted Therapy in Patients With Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT02152254|
Recruitment Status : Recruiting
First Posted : June 2, 2014
Last Update Posted : May 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Malignant Neoplasm Recurrent Malignant Neoplasm||Drug: Targeted Therapy Based on Molecular Profiling Drug: Standard-of-Care Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1362 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study Evaluating Molecular Profiling and Targeted Therapy in Patients With Metastatic Cancer)|
|Actual Study Start Date :||May 13, 2014|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Active Comparator: Arm A: Targeted Therapy
Personalized treatment, targeted therapy against the alteration based on molecular profiling.
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.
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
|Contact: Apostolia M. Tsimberidoufirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Apostolia M. Tsimberidou 713-792-4259 email@example.com|
|Principal Investigator: Apostolia M. Tsimberidou|
|Principal Investigator:||Apostolia M Tsimberidou||M.D. Anderson Cancer Center|