Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
NCT ID: NCT04211922
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2020-01-21
2022-10-11
Brief Summary
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Detailed Description
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The study is a non-control study.
The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alkotinib 400mg QD
400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.
Alkotinib Capsules
Alkotinib 400mg QD
Interventions
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Alkotinib Capsules
Alkotinib 400mg QD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have demonstrated progression during or after crizotinib treatment.
* Age 18 years or older at the time of informed consent.
* Eastern cooperative oncology group performance status (ECOG PS) of 0-2
* At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
* Willingness and ability to comply with the trial and follow-up procedures.
Exclusion Criteria
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
* Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion
18 Years
ALL
No
Sponsors
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Suzhou Zelgen Biopharmaceuticals Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Caicun Zhou, Doctor
Role: STUDY_CHAIR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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ZGALK002
Identifier Type: -
Identifier Source: org_study_id
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