TAPUR Clinical Trial: Matching Mutations to FDA approved Drugs
If you are dealing with metastatic disease and know your genetic mutations, there is a large clinical trial (called "TAPUR") that allows you to obtain FDA-approved targeted drugs that match a genomic abnormality, even when the drugs have not been approved to treat metastatic breast cancer. Very cool.
For more details, read this July 2016 article.
http://www.sharecancersupport.org/share-new/learn/blog/TAPUR
Trial website: https://clinicaltrials.gov/ct2/show/NCT02693535
Estimated Enrollment: 1030
Study Start Date: March 2016
Estimated Primary Completion Date: March 2019
TRIAL LOCATIONS include (at the moment): Idaho, Michigan, North Carolina, South Carolina.
ASCO is working to add sites across the country.
Here's the different drugs. Compare your mutations against the list below to see if there is a match.
ARMS:
Group 1 (VEGFR)
Participants receive axitinib - dosage, frequency and duration per label VEGFR mutation, amplification or overexpression)
Drug: Axitinib. Other Name: Inlyta
Group 2 (Bcr-abl, SRC, LYN, LCK)
Participants receive bosutinib- dosage, frequency and duration per label Bcr-abl, SRC, LYN, LCK mutations
Drug: Bosutinib. Other Name: Bosulif
Group 3 (ALK, ROS1, MET)
Participants receive crizotinib - dosage, frequency and duration per label ALK, ROS1, MET mutations
Drug: Crizotinib. Other Name: Xalkori
Group 4 (CDKN2A/p16, CDK4, CDK6)
Participants receive palbociclib - dosage, frequency and duration per label CDKN2A/p16 loss, CDK4, CDK6 amplifications
Drug: Palbociclib. Other Name: Ibrance
Group 5 (CSF1R, PDGFR, VEGFR)
Participants receive sunitinib - dosage, frequency and duration per label CSF1R, PDGFR, VEGFR mutations
Drug: Sunitinib. Other Name: Sutent
Group 6 (mTOR, TSC)
Participants receive temsirolimus - dosage, frequency and duration per label mTOR, TSC mutations
Drug: Temsirolimus. Other Name: Torisel
Group 7 (EGFR)
Participants receive erlotinib - dosage, frequency and duration per label EGFR mutations
Drug: Erlotinib. Other Name: Tarceva
Group 8 (ERBB2)
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label (ERBB2 amplifications)
Drug: Trastuzumab and Pertuzumab. Other Name: Herceptin and Perjeta
Group 9 (BRAFV600E)
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label BRAFV600E mutations
Drug: Vemurafenib and Cobimetinib. Other Name: Zelboraf and Cotellic
Group 10 (PTCH1)
Participants receive vismodegib - dosage, frequency and duration per label PTCH1 deletion or inactivating mutations
Drug: Vismodegib. Other Name: Erivedge
Group 11 (KRAS, NRAS and BRAF)
Participants receive cetuximab - dosage, frequency and duration per label KRAS, NRAS and BRAF wildtype
Drug: Cetuximab. Other Name: Erbitux
Group 12 (Bcr-abl, SRC, KIT, PDGFRB, EPHA2, FYN, LCK, YES1)
Participants receive dasatinib- dosage, frequency and duration per label Bcr-abl, SRC, KIT, PDGFRB, EPHA2, FYN, LCK, YES1 mutations
Drug: Dasatinib. Other Name: Sprycel
Group 13 (RET, VEGFR1/2/3, KIT, PDGFRβ, RAF-1, BRAF)
Participants receive regorafenib- dosage, frequency and duration per label RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFRβ, RAF-1, BRAF mutations/amplifications
Drug: Regorafenib. Other Name: Stivarga
Group 14 (BRCA1 / BRCA2; ATM)
Participants receive olaparib- dosage, frequency and duration per label Germline or somatic BRCA1/BRCA2 inactivating mutations; ATM mutations or deletions
Drug: Olaparib. Other Name: Lynparza
Group 15 (POLE / POLD1)
Participants receive pembrolizumab- dosage, frequency and duration per label
Drug: Pembrolizumab. Other Name: Keytruda [This is a Immunotherapy drug]
Comments
-
Is anyone actually in a Tapur trial?
-
January 2017 Update:
http://gicasym.org/daily-news/ascos-tapur-study-grows-more-100-participants-25-new-clinical-trial-sitesAs of November 15, 2016, more than 100 participants have been enrolled on a study drug as part of ASCO's Targeted Agent and Profiling Utilization Registry (TAPUR) Study. The trial launched in March 2016 at 37 sites and in November 2016 welcomed its five newest participating organizations: Cancer Treatment Centers of America, Intermountain Healthcare, Sanford Health, Swedish Cancer Institute and Providence Health & Services, and University of Nebraska Medical Center. Each of these organizations will offer TAPUR at multiple sites, although not at all of their site locations, for a total of 25 new site locations.
The TAPUR Study is designed to evaluate molecularly targeted cancer drugs and collect data on clinical outcomes to learn about additional uses of these drugs outside of indications already approved by the U.S. Food and Drug Administration (FDA). -
John - This is so interesting. As always, thanks for keeping us updated and informed!
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