Safety Studies

A Phase 1 study was completed in which patients with a variety of solid tumors were exposed to doses of Kanglaite Injection ranging from 10gm/day to 50gm/day for successive 21-day cycles. No maximum tolerated dose was identified in this study.

Anti-neoplastic Trials 

A series of Phase 2b studies are being planned to evaluate the effect of Kanglaite Injection on newly diagnosed tumors, when given concurrently with chemotherapy. These studies are in the following disease indications:

Non Small-cell Lung Cancer (NSCLC): A Phase 2b open label comparison of gemcitabine + carboplatin to gemcitabine + carboplatin + Kanglaite Injection is planned in patients with Stage IIIb or IV NSCLC. This trial is expected to enroll at least 120 patients.

Pancreatic Cancer:  A Phase 2b open label comparison of gemcitabine to gemcitabine + Kanglaite Injection in patients is planned in patients with metastatic or locally invasive pancreatic cancer that is not amenable to surgical resection. The study is designed to enroll at least 30 and up to 60 patients.

Cancer-Associated Anorexia Cachexia Syndrome Trials:

A second branch of the clinical program will focus on the treatment of the signs and symptoms of advanced cancer, especially cancer-associated anorexia cachexia syndrome (CACS).
      
CACS Study: A Phase 2 study is planned to examine the utility of Kanglaite Injection in controlling signs and symptoms of cancer in patients with very advanced malignancies.

Patients requesting more information about these trials are encouraged to visit www.clinicaltrials.gov or contact KangLaiTe USA directly at clinicaltrials@kanglaite-usa.com.