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GIST Support International - PKC-412 Interview
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PKC 412- An Interview with Charles Blanke, MD, FACP

Oregon Health and Science University

What is PKC- 412?

PKC-412, is a derivative of staurosporine (a product of Streptomyces bacteria and a potent kinase inhibitor). It is a bit more "promiscuous" than Imatinib (Gleevec). It inhibits VEGFR, PDGFR and multiple protein kinase Cs, which would make it especially attractive in patients with wild-type KIT with mutations in PDGFR.

We are now recruiting for a Phase I/II trial at Oregon Health and Science University in Portland.

What is the design of this trial?

Patients that have developed resistance to Gleevec will remain on Gleevec plus have PKC 412 added in an attempt to counter the acquired resistance. Since some areas will continue to remain stable from the Gleevec it is hoped that this combined regimen will reestablish overall stability and good effective disease control.

Will patients be able to be monitored in their local areas and periodically travel to the trial centers?

They can have some monitoring at home.

What expenses will Novartis cover, and what expenses will have to be covered by insurance or out of pocket?

Anything purely related to the trial will be covered.

What type of pre-testing will there be? What would the criteria for trial entrance be? What patients may be excluded from trial based on pre-trial evaluation?

Essentially, patients have to be resistant to Gleevec.

Must entering patients have a particular performance status (i.e. ECOG) to enter trial?

2 or better.

Would any pre-existing treatments or pre-existing treatment failures exclude a patient from trial participation (i.e. chemotherapy, embolization etc.)?

No.

So many GSI members are approaching the 2-3 year mark of successful control of disease on Imatinib, and fears of developing resistance seem to be a frequent subject of posts. What sort of advice could you offer these individuals?

Very important question. Remember that with 3 years average follow-up, almost half of the patients on my original trial are still taking the drug and thus doing well.

How can people get in touch with the trial office concerning enrollment and trial updates?

The best way to contact us concerning this and all related matters would be to write to trials@ohsu.edu

Charles D. Blanke, M.D., is the leader of the Solid Tumors Program at the OHSU Cancer Institute and associate professor of medicine (hematology and medical oncology) in the OHSU School of Medicine. He has just recently been elected chairman of the Gastrointestinal Committee of the Southwest Oncology Group (SWOG).

"This appointment both acknowledges Charles Blanke's expertise and recognizes that the OHSU Cancer Institute has internationally recognized experts in cancer research and treatment," said Grover Bagby Jr., M.D., director of the OHSU Cancer Institute. "It also validates our approach to cancer, which is to develop newer, less toxic forms of therapy and new strategies for cancer prevention based on molecular medicine."

Dr. Blanke specializes in gastrointestinal oncology and GIST at Oregon Health and Science University and is the trial director for PKC-412. He received his medical degree in 1988 from Northwestern University in Chicago. Dr. Blanke completed his residency at the Gunderson Medical Foundation in Lacrosse, and his Hematology and Oncology fellowship at Indiana University in Indianapolis.

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