Members of the Barbara Ann
Karmanos Cancer Institute phase I clinical trials program gave 13
presentations at the American Society of Clinical Oncology (ASCO) annual
meeting this year. Highlights from the presentations include three drugs
successful in phase I clinical trials and a session exploring the barriers
to phase I clinical trial approval.
Yesterday, Patricia LoRusso, D.O., leader of the Karmanos phase I
clinical trials team, led an oral discussion, "Phase I experience with
c-MET inhibitor XL880 administered orally to patients with solid tumors."
According to Dr. LoRusso, this phase I drug is particularly exciting
because it prevents tumors from growing larger and is well-tolerated by
patients. XL880 will now move to phase II trials specifically for patients
with gastric or head and neck cancers, as well as papillary renal cell
cancer. Based on the preliminary phase I data, XL880 will be a promising
drug particularly for papillary renal cell cancer, which is often resistant
to other standards of care.
In addition, Dr. LoRusso led a poster discussion presenting the
findings from her trial, "A phase 1, open-label, dose-escalation study
evaluating the safety, tolerability, and pharmacokinetics of AMG in
patients with advanced solid tumors." AMG 655 is an antibody that induces
cell death in sensitive tumor cells.
"We confirmed anti-tumor activity in patients with non-small cell lung
cancer, as well as a partial metabolic response from patients with
colorectal cancer," Dr. LoRusso said. "We will continue to study AMG 655 in
combination with other chemotherapies and targeted agents."
Also featured was a poster presentation and discussion titled, "AZD2171
in combination with various anticancer regiments: follow-up results of a
phase I multi-cohort study." According to Anthony Shields, M.D., Ph.D.,
associate center director for clinical research and program leader of
developmental therapeutics for the Barbara Ann Karmanos Cancer Institute,
the anti-vascular drug AZD2171 appears to be advantageous because it has
minimal side effects and can be taken orally. For this particular study,
AZD2171 was combined with five different standards of care, which allowed
for rapid trial accrual.
Ding Wang, M.D., Ph.D., Karmanos Cancer Institute, presented a poster
session exploring the barriers to phase I clinical trial protocol IRB
approval at Karmanos. Phase I clinical trials are vital to cancer drug
development, and this presentation will explore the ethical issues and
science behind IRB approval.
"This could not only help Karmanos physicians expedite clinical trial
approval, it could also benefit other institutions facing similar
barriers," said Dr. LoRusso. Dr. Wang discussed three objectives in this
presentation, including determining the average time spent on protocol
approval at Karmanos, identifying potential issues raised by the IRB
resulting in approval delays and identifying the redundancies for which
"standard language" implementation could facilitate future IRB
applications, thereby expediting approval.
The phase I clinical trials program at the Barbara Ann Karmanos Cancer
Institute is one of 16 National Cancer Institute funded programs in the
country, and is the largest such program in Michigan. Phase I clinical
trials test new cancer drugs on patients for the first time in order to
determine their dose-limiting toxicities.
ASCO is the world's leading professional organization representing
physicians who treat people with cancer. ASCO's members set the standard
for patient care worldwide and lead the way in carrying out clinical
research aimed at improving the prevention, diagnosis, and treatment of
cancer. ASCO's efforts are also directed toward advocating for policies
that provide access to high-quality care for all patients with cancer and
at supporting the increased funding for clinical and translational
research.
Based in midtown Detroit, the Barbara Ann Karmanos Cancer Institute is
committed to a future free of cancer. The Institute is one of 39 National
Cancer Institute-designated comprehensive cancer centers in the United
States. Caring for more than 6,000 new patients annually on a budget of
$216 million, conducting more than 700 cancer-specific scientific
investigation programs and clinical trials, the Karmanos Cancer Institute
is among the nation's best cancer centers. Through the commitment of 1,000
staff, including nearly 300 faculty members, and supported by thousands of
volunteer and financial donors, the Institute strives to prevent, detect
and eradicate all forms of cancer. John C. Ruckdeschel, M.D. is the
Institute's president and CEO.
Barbara Ann Karmanos Cancer Institute
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