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DiarrheaPhase 2NCT03486587

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

A Phase 2 study testing Bacillus Cereus tablets in people with Diarrhea and Treatment Side Effects, run by Sun Yat-sen University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diarrhea, Treatment Side Effects
What is being tested?
Bacillus Cereus tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
15 Apr 2018to 31 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

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.

Being tested
Bacillus Cereus tablets
Keywords
afatinib, diarrhea, Bacillus Cereus, NSCLC
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bacillus Cereus tabletsDrug

    Bacillus Cereus tablets was taken two tablets three times a day.

Study groups in NCT03486587
Study groupRoleWhat they receive
Changfukang® groupExperimentalPatients in Changfukang group will receive Changfukang® (Bacillus Cereus tablets).
Receives: Drug: Bacillus Cereus tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 4 weeks

Secondary outcomes (7)

  1. Diarrhoea rate of grade 2 and above

    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

    Measured: Up to 4 weeks

  2. Diarrhoea rate of grade 3 and above

    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

    Measured: Up to 4 weeks

  3. Days of diarrhoea of all grades

    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

    Measured: Up to 4 weeks

  4. Days of diarrhoea of grade 2 and above

    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

    Measured: Up to 4 weeks

  5. Days of diarrhoea of grade 3 and above

    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

    Measured: Up to 4 weeks

  6. Proportion of subjects taking anti-diarrheal medication

    Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF

    Measured: Up to 4 weeks

  7. Proportion of subjects with AEs and SAEs

    Proportion of subjects with AEs and SAEs were assessed from the start of the study until end of study as recorded in the eCRF

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2018
  2. Study start15 Apr 2018
  3. Primary completion31 Aug 2020
  4. Study completion31 Dec 2020

Why it stopped: Participants have better treatment selection, resulting in a slow recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
a single-arm, single-institutional, phase II study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03486587
Sponsor's protocol ID
2017-FXY-137
Status last verified
Sep 2021
First submitted
18 Mar 2018
Last updated
4 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bacillus Cereus tablets in people with Diarrhea and Treatment Side Effects, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Participants have better treatment selection, resulting in a slow recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diarrhoea rate of all grades (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03486587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.

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