Status:
TERMINATED
A Study Evaluating Bacillus Cereus in the Prevention of Afatinib-associated Diarrhea
Lead Sponsor:
Sun Yat-sen University
Conditions:
Diarrhea
Treatment Side Effects
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03486587
Start Date
April 15 2018
End Date
December 31 2020
Last Update
October 4 2021
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060