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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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21 June 2021 |
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Main ID: |
TCTR20210129007 |
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Date of registration:
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29/01/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase IIa Clinical Trial for Dose-Finding, Pharmacokinetics, Safety, Immunomodulatory Activity, and Inhibitory Activity on Cancer Progression of Capsule Formulation of the Standardized Extarct of Atractylodes lancea in Patients with Unresectable or Metastatic Liver Tumor
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Scientific title:
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Phase IIa Clinical Trial for Dose-Finding, Pharmacokinetics, Safety, Immunomodulatory Activity, and Inhibitory Activity on Cancer Progression of Capsule Formulation of the Standardized Extarct of Atractylodes lancea in Patients with Unresectable or Metastatic Liver Tumor |
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Date of first enrolment:
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01/03/2021 |
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Target sample size:
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90 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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www.thaiclinicaltrials.org/show/TCTR20210129007 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 2
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Juntra
Karbwang |
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Address:
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Thammasat University (Rangsit campus), 99 Mu 18, Paholyothin Road, Long Luang
12120
Pathumtanee
Thailand |
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Telephone:
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0836090000 |
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Email:
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karbwangj@yahoo.com |
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Affiliation:
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Thammasat University |
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Name:
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Kesara
NaBangchang |
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Address:
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Thammasat University (Rangsit campus), 99 Mu 18, Paholyothin Road, Long Luang
12120
Pathumtanee
Thailand |
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Telephone:
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0818111678 |
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Email:
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kesaratmu@yahoo.com |
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Affiliation:
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Thammasat University |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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cholangiocarcinoma,
Atractylodes lancea
standardized extract
phase IIa clinical trial
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late-stage cholangiocarcinoma
cholangiocarcinoma,
Atractylodes lancea
standardized extract
phase IIa clinical trial
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Intervention(s)
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1 capsule formulation consists of 601 mg A. lancea standardized extract of A. lacea,1 capsule formulation consists of 601 mg A. lancea standardized extract of A. lacea,standard supportive care for cholangiocarcinoma patients
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A. lancea at 1,000 mg per day for 90 days together with standard supportive care,A. lancea at 1,000 mg per day for 14 days, followed by 1,500 mg for 14 days, followed by 2,000 mg for 62 days together with standard supprtive caretogether with standard supporting care,standard supportive care
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Experimental Drug,Experimental Drug,No Intervention No treatment
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Primary Outcome(s)
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pharmacokinetic parameters Day 0 (at 0, 0.5, 1, 1.5, 2, 2.5, 3,4,5 and 6 hours); day 15 (at 0,0.5,1,1.5,2.5,3,4,5,6 hours); day 29 (at 0,0.5,1,1.5,2,2.5,3,4.5 and 6 hours) pharmacokinetic analysis
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Secondary Outcome(s)
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adverse events weekly for 4 months clinical signs and symptoms and laboratory tests
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Source(s) of Monetary Support
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National Research Council of Thailand (NRCT)
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Ethics review
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Status: Submitted, approved
Approval date: 04/01/2021
Contact:
ec.medtu@gmail.com
ec.medtu@gmail.com
029269704 Ext.
ec.medtu@gmail.com
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/08/2021 |
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URL:
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