J Cancer 2017; 8(10):1872-1883. doi:10.7150/jca.15407

Research Paper

A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer

Lee S. Schwartzberg1, Francis P. Arena2, Bryan J. Bienvenu3, Edward H. Kaplan4, Luis H. Camacho5, Luis T. Campos6, J. Paul Waymack7, Mary A. Tagliaferri7, Michael M. Chen7, Dapeng Li7✉

1. West Cancer Center, Germantown, TN
2. Arena Oncology Associates, New York, NY
3. Mary Bird Perkins Cancer Center, Baton Rouge, LA
4. Hematology Oncology of the North Shore, IL
5. St. Luke's Cancer Center, Houston, TX
6. Oncology Consultants, Houston, TX
7. KangLaiTe USA, Redwood City, CA

Abstract

Background: This study was designed to assess the safety and preliminary efficacy of KLTi plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer.

Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreatic cancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Three sequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at 1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and 15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primary endpoint was progression-free survival in the ITT population. Safety evaluation was based on patients who received any study treatment. ClinicalTrials.gov identifier NCT00733850.

Results: Eighty-five patients were randomized including 41 (28:13) in Cohort 1, 18 (12:6) in Cohort 2, and 26 (17:9) in Cohort 3. Due to a different dose and/or shift in patient populations in Cohort 2 and 3, efficacy data for the 30 gm dose are presented in this manuscript for Cohort 1 alone, and for the combination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significant improvement in progression-free survival (PFS) as assessed by blinded independent radiology review in the ITT population, with a median of 112 days, versus 58 days in the gemcitabine group (HR 0.50; 95% CI: 0.27, 0.92), p = 0.0240. The incidence rates of TEAEs, CTCAE Grade 3 or higher TEAEs, and SAEs were similar between the two arms. There were no deaths related to KLTi + gemcitabine treatment.

Conclusion: Kanglaite Injection (30 g/day) plus a standard regimen of gemcitabine demonstrated encouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.

Keywords: Kanglaite Injection, pancreatic cancer, coix seed, traditional Chinese medicinal herb.

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) license (https://creativecommons.org/licenses/by-nc/4.0/). See http://ivyspring.com/terms for full terms and conditions.
How to cite this article:
Schwartzberg LS, Arena FP, Bienvenu BJ, Kaplan EH, Camacho LH, Campos LT, Waymack JP, Tagliaferri MA, Chen MM, Li D. A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer. J Cancer 2017; 8(10):1872-1883. doi:10.7150/jca.15407. Available from http://www.jcancer.org/v08p1872.htm