Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
Gemcitabine is usually used to treat cancer of the pancreas. The purpose of this study is to
determine if Kanglaite Injection (KLT) is safe in patients with cancer of the pancreas, and
whether it improves the effectiveness of gemcitabine. Additionally, the effect, if any, of
KLT on the signs and symptoms of cancer as well as the common side effects of chemotherapy
will be evaluated.
The research drug, KLT, is purified from a traditional Chinese medicine called coix seed. It
is approved in China for use in combination with chemotherapy to treat patients with advanced
lung cancer and liver cancer. It is also approved in China for use by itself to treat the
symptoms of cancer in patients with advanced cancer of any kind. In the US, KLT is purely
experimental and is not approved for any use. While a small number of cancer patients in the
US have received KLT alone in a Phase I study, this is the first US protocol to evaluate
whether or not KLT is useful in pancreatic cancer.
This phase II clinical study was completed in the US in June 2014. The clinical study report
was submitted to the FDA in January 2015. The designs of the phase III clinical study for KLT
has been cleared by the FDA in May 2015 and will be launched soon.