NCT03486587|TerminatedPhase 2DMCFDA Drug
Study Stopped
Participants have better treatment selection, resulting in a slow recruitment.
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Participants have better treatment selection, resulting in a slow recruitment.
A Single-arm, Single-institutional, Phase II Study Evaluating the Efficacy and Safety of Bacillus Cereus (Changfukang®) in the Prevention of Afatinib-associated Diarrhea in NSCLC Patients
Sponsor study identifier
interventional
12
1 country
1
Study Start
April 15, 2018
Actual (reported)Primary Completion
August 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Afatinib is an irreversible ErbB-family blocker with approved clinical activity in non-small-cell lung cancer (NSCLC) with EGFR mutations. It has received regulatory approval for use as a treatment for patients with lung adenocarcinoma whose tumors harbour activating EGFR mutations within exons 18-21 of the EGFR receptor, or patients with lung squamous cell carcinoma whose disease progress after platinum-based doublet chemotherapy. However, diarrhea is the most commonly reported adverse events associated with afatinib treatment (\> 90%). Although these events are generally mild to moderate in severity, diarrhea adversely affects the tolerability of cancer treatment, and in severe cases diarrhea has the potential to affect the efficacy of treatment due to poor compliance, or treatment interruption, or dosage reduction. Currently, no prophylactic measure was demonstrated efficaciously. Bacillus cereus is an aerobic spore-forming bacterium that is commonly found in soil. The efficacy of Bacillus cereus in the management of afatinib treatment-associated diarrhoea has not been extensively evaluated in clinical studies. This is a single-arm, single-institutional, phase II study evaluating the efficacy and safety of Bacillus cereus (Changfukang®) in the prevention of afatinib-associated diarrhea in NSCLC patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2018
Actual (reported)April 3, 2018
Actual (reported)April 15, 2018
Actual (reported)August 31, 2020
Actual (reported)December 31, 2020
Actual (reported)Diarrhoea rate of all grades
Proportion of subjects experiencing diarrhoea of all grades, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF)
Up to 4 weeks
Diarrhoea rate of grade 2 and above
Up to 4 weeks
Diarrhoea rate of grade 3 and above
Up to 4 weeks
Days of diarrhoea of all grades
Up to 4 weeks
Days of diarrhoea of grade 2 and above
Up to 4 weeks
Days of diarrhoea of grade 3 and above
Up to 4 weeks
Overall Response Rate
Up to 4 weeks
Clinical Benefit Response
Up to 4 weeks
Progression-free Survival
Up to 4 weeks
Patients in Changfukang group will receive Changfukang® (Bacillus Cereus tablets).
Bacillus Cereus tablets was taken two tablets three times a day.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Li Zhang, MD
Sun Yat-sen University
12 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2018
First Posted
April 3, 2018
Study Start
April 15, 2018
Actual (reported)Prevention of Traveler's Diarrhea
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
October 4, 2021
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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