A randomized, open-label, safety and exploratory efficacy study of Kanglaite Injection (KLTi) plus gemcitabine versus gemcitabine in patients with advanced pancreatic cancer

Lee Schwartzberg, Francis P. Arena, Bryan J. Bienvenu, Edward H. Kaplan, Luis H. Camacho, Luis T. Campos, J. Paul Waymack, Mary A. Tagliaferri, Michael M. Chen, Dapeng Li

Research output: Contribution to journalArticle

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Abstract

Background: This study was designed to assess the safety and preliminary efficacy of KLTi plusgemcitabine in patients with locally advanced or metastatic pancreatic cancer.Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreaticcancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Threesequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primaryendpoint was progression-free survival in the ITT population. Safety evaluation was based on patientswho 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 thecombination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significantimprovement in progression-free survival (PFS) as assessed by blinded independent radiology review inthe 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 SAEswere 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 demonstratedencouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.

Original languageEnglish (US)
Article number15407
Pages (from-to)1872-1883
Number of pages12
JournalJournal of Cancer
Volume8
Issue number10
DOIs
StatePublished - Jun 3 2017

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gemcitabine
Pancreatic Neoplasms
Safety
Injections
Disease-Free Survival
Population
kang-lai-te
Radiology
Disease Progression
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology

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A randomized, open-label, safety and exploratory efficacy study of Kanglaite Injection (KLTi) plus gemcitabine versus gemcitabine in patients with advanced pancreatic cancer. / Schwartzberg, Lee; Arena, Francis P.; Bienvenu, Bryan J.; Kaplan, Edward H.; Camacho, Luis H.; Campos, Luis T.; Waymack, J. Paul; Tagliaferri, Mary A.; Chen, Michael M.; Li, Dapeng.

In: Journal of Cancer, Vol. 8, No. 10, 15407, 03.06.2017, p. 1872-1883.

Research output: Contribution to journalArticle

Schwartzberg, L, Arena, FP, Bienvenu, BJ, Kaplan, EH, Camacho, LH, Campos, LT, Waymack, JP, Tagliaferri, MA, Chen, MM & Li, D 2017, 'A randomized, open-label, safety and exploratory efficacy study of Kanglaite Injection (KLTi) plus gemcitabine versus gemcitabine in patients with advanced pancreatic cancer', Journal of Cancer, vol. 8, no. 10, 15407, pp. 1872-1883. https://doi.org/10.7150/jca.15407
Schwartzberg, Lee ; Arena, Francis P. ; Bienvenu, Bryan J. ; Kaplan, Edward H. ; Camacho, Luis H. ; Campos, Luis T. ; Waymack, J. Paul ; Tagliaferri, Mary A. ; Chen, Michael M. ; Li, Dapeng. / A randomized, open-label, safety and exploratory efficacy study of Kanglaite Injection (KLTi) plus gemcitabine versus gemcitabine in patients with advanced pancreatic cancer. In: Journal of Cancer. 2017 ; Vol. 8, No. 10. pp. 1872-1883.
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abstract = "Background: This study was designed to assess the safety and preliminary efficacy of KLTi plusgemcitabine in patients with locally advanced or metastatic pancreatic cancer.Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreaticcancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Threesequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primaryendpoint was progression-free survival in the ITT population. Safety evaluation was based on patientswho 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 thecombination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significantimprovement in progression-free survival (PFS) as assessed by blinded independent radiology review inthe 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 SAEswere 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 demonstratedencouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.",
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AU - Arena, Francis P.

AU - Bienvenu, Bryan J.

AU - Kaplan, Edward H.

AU - Camacho, Luis H.

AU - Campos, Luis T.

AU - Waymack, J. Paul

AU - Tagliaferri, Mary A.

AU - Chen, Michael M.

AU - Li, Dapeng

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N2 - Background: This study was designed to assess the safety and preliminary efficacy of KLTi plusgemcitabine in patients with locally advanced or metastatic pancreatic cancer.Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreaticcancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Threesequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primaryendpoint was progression-free survival in the ITT population. Safety evaluation was based on patientswho 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 thecombination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significantimprovement in progression-free survival (PFS) as assessed by blinded independent radiology review inthe 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 SAEswere 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 demonstratedencouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.

AB - Background: This study was designed to assess the safety and preliminary efficacy of KLTi plusgemcitabine in patients with locally advanced or metastatic pancreatic cancer.Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreaticcancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Threesequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primaryendpoint was progression-free survival in the ITT population. Safety evaluation was based on patientswho 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 thecombination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significantimprovement in progression-free survival (PFS) as assessed by blinded independent radiology review inthe 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 SAEswere 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 demonstratedencouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.

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