Download How to Find and Participate in a GIST clinical trial

(aka---how to know where to look and who to call)
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Rare disease, 5000-7000 new cases of GIST
every year
Compare 230,000 new invasive breast CA
cases/year
GIST studies tend to be opened at fewer sites
 OHSU(Portland), Dana Farber (Boston), Fox
Chase (Philadelphia), MD Anderson (Houston),
Memorial Sloan Kettering (New York)
9
12
2
4
12
1
1 1
2
1
1
1
1
1
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Oregon - 12
California -12
Washington - 9
Colorado - 4
Nebraska - 2
Alaska
Arkansas
Hawaii
Idaho -2
Illinois
Indiana
Michigan
South Carolina
Tennessee
Nigeria
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Phase I: Researchers test a new drug or treatment in a small group of people for
the first time to evaluate its safety, determine a safe dosage range, and identify
side effects.
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Phase II: The drug or treatment is given to a larger group of people to see if it is
effective and to further evaluate its safety.
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Phase III: The drug or treatment is given to large groups of people to confirm its
effectiveness, monitor side effects, compare it to commonly used treatments,
and collect information that will allow the drug or treatment to be used safely.
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Phase IV: Studies are done after the drug or treatment has been marketed to
gather information on the drug's effect in various populations and any side
effects associated with long-term use
Source: http://www.nlm.nih.gov/services/ctphases.html
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Check with your insurance
 Does your insurance allow you to participate?
 Myth: Clinical trials do NOT “pay for everything”
 As of January 1, 2014, the Affordable Care Act
(ACA) includes the requirement that private
insurers cover routine costs during participation
in a clinical trial
 At OHSU we will check this for you prior to study
participation
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KIT (exon 9/11/13/17)
PDGFRA D842V (exon 12/14/18)
Wild Type--- what does that mean?
Recommend getting tissue mutation testing
ASAP (with first biopsy or surgery)
At a minimum, mutation testing after
Imatinib (Gleevec) failure
Do not usually need another biopsy/surgery
to get this done
KIT Exon 8
0.1%
KIT Exon 9
8%
KIT
Exon 17
KIT Exon 13
1%
2%
PDGFRA Exon 12
2%
PDGFRA Exon 14
0.1%
PDGFRA Exon 18 other
3%
KIT Exon 11
65%
SHDA/B/C/D Mutation
(Carney-Stratakis)
6%
BRAF
2%
NF1
0.2%
Source: Michael Heinrich, MD
RAS gene mutation
0.1%
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Date of diagnosis
Keep a copy of your pathology report(s)
Date(s) of surgery(ies) and location(s) where
surgery was done
Previous treatments and dates (why did you
come off treatment?)---be specific (was it for
progression or for symptoms?)
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https://www.molecularmatch.com/
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https://clinicaltrials.gov/
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BLU-285
 Phase 1 oral TKI drug
 Several sites open around the world
 Visits weekly for the first month then roughly monthly
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KTN-158
 Phase 1 intravenous antibody drug
 OHSU can enroll 1-3 patients/month for now
 Requires infusion every 3 weeks indefinitely
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SARC 029 trial
 Likely to open later this summer
 Phase II study combining two different oral drugs
Tracy Walker, RN, BSN
OHSU Knight Cancer Institute
 [email protected]
 503-346-1183
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