Study Summary
This trial is testing whether targeted therapy based on a tumor's genetic profile is more effective than standard treatment for metastatic cancer.
Eligible Conditions
- Metastatic Cancer
- Recurrent Malignant Neoplasm
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Continuous Monitoring, expected range from 2 months to 3 years
Year 3
Comparison of Progression-Free Survival (PFS) Between the Two Randomized Arms
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Arm A: Targeted Therapy
1 of 2
Arm B: Standard-of-Care Therapy
1 of 2
Active Control
Experimental Treatment
1362 Total Participants · 2 Treatment Groups
Primary Treatment: Standard-of-Care Therapy · No Placebo Group · N/A
Arm B: Standard-of-Care Therapy
Drug
Experimental Group · 1 Intervention: Standard-of-Care Therapy · Intervention Types: DrugArm A: Targeted Therapy
Drug
ActiveComparator Group · 1 Intervention: Targeted Therapy Based on Molecular Profiling · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: continuous monitoring, expected range from 2 months to 3 years
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,789,017 Total Patients Enrolled
Tempus LabsIndustry Sponsor
10 Previous Clinical Trials
4,318 Total Patients Enrolled
Apostolia M TsimberidouPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
36 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient has biopsy-accessible tumor; for patients who had no prior anticancer therapy and had surgical resection within a year and tumor tissue is immediately available, that tumor will be analyzed and no biopsy will be needed.
You have measurable disease.\n
You have a performance status of 0-1.
You have a platelet count of at least 100,000/ul.
You have a total bilirubin level of 1.5 x the ULN or less.
References
- Naqvi, Mohammad Faraz, Henry Hiep Vo, David Vining, and Apostolia-Maria Tsimberidou. 2021. “Prolonged Response to Treatment Based on Cell-free DNA Analysis and Molecular Profiling in Three Patients with Metastatic Cancer: A Case Series”. Therapeutic Advances in Medical Oncology. SAGE Publications. doi:10.1177/17588359211001538.
- Aletaha, D, F Alasti, and JS Smolen. 2016. “Disease Activity States of the DAPSA, a Psoriatic Arthritis Specific Instrument, Are Valid Against Functional Status and Structural Progression”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/annrheumdis-2016-209511.
- Vo HH, Fu S, Hong DS, Karp DD, Piha-Paul S, Subbiah V, Janku F, Naing A, Yap TA, Rodon J, Ajani JA, Cartwright C, Johnson A, Song IW, Beck J, Kahle M, Nogueras-Gonzalez GM, Miller V, Chao C, Vining DJ, Berry DA, Meric-Bernstam F, Tsimberidou AM. Challenges and opportunities associated with the MD Anderson IMPACT2 randomized study in precision oncology. NPJ Precis Oncol. 2022 Oct 27;6(1):78. doi: 10.1038/s41698-022-00317-0.
- 2014. "Initiative for Molecular Profiling and Advanced Cancer Therapy (IMPACT II)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02152254.
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Conditions
Cancer Related
Treatments