NCT02437617|Completed
Genomic Profiling Assay in Phase I
A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
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A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
Sponsor study identifier
observational
500
1 country
1
Study Start
July 13, 2012
Actual (reported)Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)The goal of this research study is to collect and test tumor tissue from patients with advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers will study if the results from genetic testing can help researchers determine which therapy may prove more beneficial for a patient in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2012
Actual (reported)May 4, 2015
Actual (reported)May 7, 2015
Actual (reported)June 1, 2021
Actual (reported)June 1, 2021
Actual (reported)Response Rate
Response rate of each of the three cohorts (matched targeted therapy group, control group #1 and control group #2) calculated along with its 95% confidence interval. Response rate defined as proportion of participants who experience complete response (CR) or partial response (PR). Clinical response evaluated according to the RECIST 1.1.
6 months
Participants who have had tumor molecular analysis performed with the similar clinical characteristics and genomic aberrations but who receive therapy not matched to their aberrations, or who have received results from Foundation Medicine that fail to demonstrate any molecular alteration.
Participants from historical archives of MD Anderson, no older than two years, who received therapy not matched to their aberrations and are matched not only on the basis of the clinical characteristics, but also, as much as possible, on the basis of genomic aberrations.
Participants with tumor aberrations who received matched targeted therapy.
Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants from MDACC/Phase I historical archives, and participants actively on MDACC/Phase I studies.
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Wheler JJ, Janku F, Naing A, Li Y, Stephen B, Zinner R, Subbiah V, Fu S, Karp D, Falchook GS, Tsimberidou AM, Piha-Paul S, Anderson R, Ke D, Miller V, Yelensky R, Lee JJ, Hong DS, Kurzrock R. Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. Cancer Res. 2016 Jul 1;76(13):3690-701. doi: 10.1158/0008-5472.CAN-15-3043. Epub 2016 May 18.
Tumor specimens collected from patients for DNA extraction. All samples residual samples from previously performed biopsies.
Funda Meric-Bernstam, MD
M.D. Anderson Cancer Center
500 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2015
First Posted
May 7, 2015
Study Start
July 13, 2012
Actual (reported)Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 1, 2021
Actual (reported)Last Updated
June 14, 2021
Record last verified: 2021-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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