Safety and Exploratory Efficacy of Kanglaite Injection in Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00733850|
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : June 19, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Kanglaite Injection plus gemcitabine Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection Plus Gemcitabine (G+K) Versus Gemcitabine in Patients With Advanced Pancreatic Cancer|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Kanglaite Injection plus Gemcitabine
Drug: Kanglaite Injection plus gemcitabine
Intravenous repeating dose
Other Name: KLT
Active Comparator: 2
Intravenous repeating dose
Other Name: Gemzar
- Progression-free survival [ Time Frame: Length of study ]
- Objective Response Rate [ Time Frame: Length of study ]
- Survival [ Time Frame: From randomization until death from any cause ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733850
|Principal Investigator:||Lee S Schwartzberg, MD||The West Clinic|