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Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)

Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401) - Phase II study of the effectiveness of prophylaxis against side effects associated with Afatinib (NLCTG 1401)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016167
Enrollment
30
Registered
2015-01-09
Start date
2015-01-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

loperamide,minocyclin,minocycline hydrochloride,azulene sodium sulfonate

Sponsors

Niigata Lung Cancer Treatment Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Non-small cell lung cancer proven by histology and/or cytology 2.EGFR mutation status is positive 3.Performance Status(ECOG)0-2 4.Afatinib has not been administered in the past 5.Chest radiation therapy that has not been enforced within the registration before 4 weeks 6.Adequate organ function 7.20 years or older 8.Written Informed Consent

Exclusion criteria

Exclusion criteria: (1)History of active double cancer (2)No intention to birth control (3)Unstable psychic disorder (4)Interstitial pneumonia or active radiation pneumonia or drug-induced pneumonia (5)Ileus (6)Patients who can not take oral drugs (7)Severe complications (8)Patients in drug and tetracycline drug used in the present study a history of hypersensitivity (9)Decision of ineligibility by a physician.

Design outcomes

Primary

MeasureTime frame
In 4 weeks time Severe diarrhea expression inhibition rate (Severe diarrhea:Diarrhea that is deemed necessary dose reduction of Afatinib dose reduction criteria defined in the protocol

Countries

Japan

Contacts

Public ContactMasaaki Okajima

Niigata University Medical & Dental Hospital Respiratory and infectious diseases internal medicine

okajima-nii@umin.ac.jp025-227-2200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026