NCT00733850

Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer

A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: KangLaiTe USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Kanglaite Injection plus gemcitabine	Intravenous repeating dose
DRUG	Gemcitabine	Intravenous repeating dose

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2008-08-13
• Last updated: 2015-06-19

Locations

42 sites across 1 country: United States