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Oct 17, 2016
 |  BioCentury  |  Product Development

Yes we PanCAN

How PanCAN's platform trial may boost participation in pancreatic cancer trials

A major goal of a new multidrug platform study organized by the Pancreatic Cancer Action Network is to meet patients' needs better than traditional trials do. Among other things, that means accepting patients who have had a wide range of prior therapies and allowing them to cross over to new treatments following progression. It also means incorporating individual patient preferences into the randomization algorithms.

PanCAN believes Precision Promise will dramatically increase the proportion of pancreatic cancer patients who participate in clinical trials, which Chief Research Officer Lynn Matrisian told BioCentury has been a barrier to development of new treatments.

Only about 4% of patients participate in clinical trials, corresponding to roughly 2,000 patients in the U.S. each year. Matrisian said competition for patients means pancreatic cancer trial readouts are often delayed or never happen.

Reasons for low participation include strict enrollment criteria that limit prior therapies, distance from a participating trial site and lack of awareness of appropriate trials.

Enrollment criteria have not yet been determined. But Matrisian told BioCentury, "We are aiming to relax as many of the standard exclusion criteria as possible and have substudies for all lines of therapy."

Precision Promise should not only enable more patients to participate, but also should allow them to remain on study longer due to the range of treatments tested and the ability to cross over.

"Patients will have access to first-, second- and third-line clinical trial options," said Victoria Manax Rutson, PanCAN's CMO. Upon progression, she added, " A patient can shift from one option to the next very quickly without having to enroll in another trial."

Matrisian added that, during screening, patients will be able to weigh in on whether they can meet a given regimen's demands. For example, treatment assignments will take into account how often patients can come in for treatment and monitoring, and what kinds of side effects they feel they can tolerate.

Treatments will be assigned according to algorithms designed by pancreatic researchers, clinicians and industry partners, in some cases with the help of a tumor board. The assignments will take into account molecular profiling of patients' tumors and the tumor microenvironment, as well as patient preference factors.

Precision Promise will use a master protocol, a standing network of trial sites, and a common infrastructure for enrollment and data collection, sharing and analysis. Twelve sites across the U.S. have been selected so far.

Matrisian said the treatment regimens may include approved pancreatic cancer therapies, products approved for other cancers and investigational agents.

At launch the...

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