Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.
NCT ID: NCT03130881
Last Updated: 2020-03-04
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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UNKNOWN
PHASE1
60 participants
INTERVENTIONAL
2016-11-08
2021-12-30
Brief Summary
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Detailed Description
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PLB1003 is a potent selective ALK inhibitor. PLB1003 acts on cancer by blocking abnormal ALK-mediated signaling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PLB1003
ALK-positive (ALK+) advanced NSCLC
PLB1003
PLB1003 is a capsule and is administered orally.
Interventions
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PLB1003
PLB1003 is a capsule and is administered orally.
Eligibility Criteria
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Inclusion Criteria
* Age≥18 years
* Diagnosed with a locally advanced or metastatic non-small cell lung cancer that has progressed despite standard therapy.
* Must have evidence of ALK positivity from the results of molecular pre-screening evaluations
* At least one measurable lesion as per RECIST v1.1
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
* ECOG Performance Status of 0-2
Exclusion Criteria
* Clinically significant, uncontrolled heart diseases. Unstable angina. History of documented congestive heart failure (New York Heart Association functional classification III-IV) .
* Active peptic ulcer disease or gastritis
* Major surgery within 4 weeks prior to starting PLB1003
* Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1003..
* Pregnant or nursing women
* Involved in other clinical trials \< 30 days prior to Day 1
18 Years
ALL
No
Sponsors
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Beijing Pearl Biotechnology Limited Liability Company
INDUSTRY
Responsible Party
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Principal Investigators
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Baohui Han, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HMO-PLB1003-20160828
Identifier Type: -
Identifier Source: org_study_id
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