Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Evaluating Bacillus Cereus in the Prevention of Afatinib-associated Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486587
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Li Zhang, MD, Sun Yat-sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Treatment Side Effects Drug: Bacillus Cereus tablets Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: a single-arm, single-institutional, phase II study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: Changfukang® group
Patients in Changfukang group will receive Changfukang® (Bacillus Cereus tablets).
Drug: Bacillus Cereus tablets
Bacillus Cereus tablets was taken two tablets three times a day.




Primary Outcome Measures :
  1. Diarrhoea rate of all grades [ Time Frame: Up to 4 weeks ]
    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)


Secondary Outcome Measures :
  1. Diarrhoea rate of grade 2 and above [ Time Frame: Up to 4 weeks ]
    Proportion of subjects experiencing diarrhoea of grade 2 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF

  2. Diarrhoea rate of grade 3 and above [ Time Frame: Up to 4 weeks ]
    Proportion of subjects experiencing diarrhoea of grade 3 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF

  3. Days of diarrhoea of all grades [ Time Frame: Up to 4 weeks ]
    Number of days of subjects experiencing diarrhoea of all grades, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF

  4. Days of diarrhoea of grade 2 and above [ Time Frame: Up to 4 weeks ]
    Number of days of subjects experiencing diarrhoea of grade 2 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF

  5. Days of diarrhoea of grade 3 and above [ Time Frame: Up to 4 weeks ]
    Number of days of subjects experiencing diarrhoea of grade 3 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF

  6. Proportion of subjects taking anti-diarrheal medication [ Time Frame: Up to 4 weeks ]
    Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF

  7. Proportion of subjects with AEs and SAEs [ Time Frame: Up to 4 weeks ]
    Proportion of subjects with AEs and SAEs were assessed from the start of the study until end of study as recorded in the eCRF


Other Outcome Measures:
  1. Overall Response Rate [ Time Frame: Up to 4 weeks ]
    Overall response rate as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  2. Clinical Benefit Response [ Time Frame: Up to 4 weeks ]
    Clinical benefit response as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

  3. Progression-free Survival [ Time Frame: Up to 4 weeks ]
    Progression-free Survival as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed locally advanced or metastastic non-small-cell lung cancer
  • Suitable for the treatment of afatinib assessed by investigator
  • Age >=18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Life expectancy of at least 12 weeks
  • Able to swallow and retain oral medications
  • Women of childbearing potential must agree and commit to the use of a highly effective non-hormonal method of contraception, ie, intrauterine device, bilateral tubal ligation, vasectomized partner, or abstinence (only when it is the preferred lifestyle of the patient), from the time of informed consent until 28 days after the last dose of the investigational products. Men and their female partners of childbearing potential must agree and commit to use a highly effective method of contraception (ie, any of the above methods or hormonal contraception associated with inhibition of ovulation) while on treatment and for 3 months after last dose of investigational products
  • Provide written, informed consent to participate in the study and follow the study procedures
  • Patient has adequate bone marrow as defined by the following laboratory values:

    • White blood cell ≥ 3.0 × 109/L
    • Absolute neutrophil count ≥ 1.5 × 109/L
    • Platelets ≥ 75 × 109/L
  • Patient has adequate organ function as defined by the following laboratory values:

    • In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN
    • Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range of the central laboratory in patients with well documented
    • Gilbert's Syndrome
    • Serum creatinine ≤ 1.5 × ULN

Exclusion Criteria:

  • Previous treatment with EGFR-TKI or anti-EGFR antibody
  • History of gastrointestinal disease with diarrhea as the primary symptom in the last three months.
  • Another malignancy within 3 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
  • Diagnosed as having CNS metastases, except those whose CNS disease were stable and dehydration treatment were unrequired within 4 weeks prior to the first dose of afatinib
  • Any severe and / or uncontrolled medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486587


Contacts
Layout table for location contacts
Contact: Qiufan Zheng, MD 13422154217 zhengqf@sysucc.org.cn
Contact: Wenfeng Fang, MD fangwf@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang, M.D.       zhangli6@mail.sysu.edu.cn   
Principal Investigator: Li Zhang, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Li Zhang, MD Sun Yat-sen University

Layout table for additonal information
Responsible Party: Li Zhang, MD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03486587    
Other Study ID Numbers: 2017-FXY-137
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Li Zhang, MD, Sun Yat-sen University:
afatinib
diarrhea
Bacillus Cereus
NSCLC
Additional relevant MeSH terms:
Layout table for MeSH terms
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms