Status:
UNKNOWN
Prevention and Treatment of Pyrrolitinib-associated Diarrhea
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
In this study, patients taking pyrrolitinib alone or combined with pyrrolitinib were recruited (170 cases of secondary prevention and 300 cases of non-secondary prevention). Non-secondary prevention:...
Detailed Description
The study can only be formally carried out with the written approval of the ethics committee. Investigators regularly submit annual research reports to the ethics committee. Investigators will inform ...
Eligibility Criteria
Inclusion
- One of the following two situations:
- A) Plan to take pyrrolitinib for ≥21 days; B) Third-degree diarrhea or second-degree diarrhea with complications after taking pyrrolitinib at present, plan to take pyrrolitinib for ≥21 days;
- Age ≥18 years;
- ECOG PS 0-2;
- Life expectancy ≥6 months;
- Participate in this study voluntarily, sign informed consent, have good compliance and are willing to cooperate with the follow-up.
Exclusion
- May be allergic to pyrrolitinib or excipients;
- There are many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting;
- Patients with biliary obstruction;
- Participate in other diarrhea-related clinical trials;
- Pregnant and lactating women, fertile women who tested positive in the baseline pregnancy test, or women of childbearing age who were unwilling to use effective contraception during the whole trial period;
- Concomitant diseases (including but not limited to severe hypertension beyond the control of drugs, severe diabetes, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study; The investigator concluded that the patient was not eligible for any of the other conditions in the study.
Key Trial Info
Start Date :
May 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT04736186
Start Date
May 16 2020
End Date
April 30 2023
Last Update
February 3 2021
Active Locations (1)
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1
TianJin Medical University Cancer Institute and Hospital
Tianjin, China, 300060