Trial intelligence / Profile preview

Oral Kanglaite for Rising PSA in Prostate Cancer

NCT01483586Phase 2

Key facts

Status
Terminated
Start
Nov 2011
Primary completion
Dec 2013
Countries
1
Modality
HM (Herbal Medicine)
Conditions
prostate cancer (PCa)
01

Overview

Phase 2, randomised, open-label trial of kanglaite in prostate cancer (PCa) (2 arms), sponsored by Zhejiang Kanglaite Pharmaceutical Co., Ltd. Primary endpoint: Prostate Specific Antigen Doubling Time at 12 months. Started Nov 2011; status: terminated.

02

Design

2 arms
Study design
RandomizedOpen-label
  • KLTc High Dose

    6 KLTc gelcaps taken four times a day

  • KLTc Low Dose

    3 KLTc gelcaps taken four times a day

03

Endpoints

Primary

  • Prostate Specific Antigen Doubling Time

Secondary

  • PSA Objective Response

  • KLTc Intake Compliance

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