Trial intelligence / Profile preview

Kanglaite Injection plus Gemcitabine in Advanced Pancreatic Cancer

NCT00733850Phase 2

Key facts

Status: Completed
Start: Aug 2008
Primary completion: Jun 2014
Countries: 1
Sponsor: Zhejiang Kanglaite Pharmaceutical Co., Ltd.
Modality: HM (Herbal Medicine)

Drugs: kanglaite
Conditions: pancreatic cancer (PC)

Overview

Phase 2, randomised, open-label trial of kanglaite in pancreatic cancer (PC) (2 arms), sponsored by Zhejiang Kanglaite Pharmaceutical Co., Ltd. Primary endpoint: Progression-Free Survival. Started Aug 2008; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Kanglaite Injection plus Gemcitabine
Kanglaite Injection (30g or 50g) + Gemcitabine
Gemcitabine
Gemcitabine monotherapy

Who it enrols

Patients with histologically confirmed locally invasive or metastatic pancreatic cancer, no prior chemotherapy for metastatic disease, and adequate organ function.

Endpoints

Primary

Progression-Free SurvivalLength of study

Secondary

Objective Response RateLength of study
Overall SurvivalFrom randomization until death from any cause

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