This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
NCT ID: NCT04254471
Last Updated: 2020-02-05
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
PHASE2/PHASE3
313 participants
INTERVENTIONAL
2019-11-14
2022-11-22
Brief Summary
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Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Dose escalation (AL3810 + carboplatin + etoposide)
Phase II:Participants will receive AL3810 orally in combination with carboplatin and etoposide during the Cycles 1-4 . AL3810 dose escalated form 5mg to 10mg step-up to determine the recommended dose of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.
AL3810
5mgQD, 7.5mgQD, 10mgQD
carboplatin + etoposide
Carboplatin and etoposide are background treatment.
AL3810+ carboplatin + etoposide
Phase III:Participants will receive AL3810(recommended dose will be determined by safety monitoring committee (SMC) in Phase II) orally in combination with carboplatin and etoposide during the Cycles 1-4. Thereafter, participants will receive maintenance AL3810 until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
AL3810
5mgQD, 7.5mgQD, 10mgQD
carboplatin + etoposide
Carboplatin and etoposide are background treatment.
Placebo+ carboplatin + etoposide
Phase III:Participants will receive placebo orally in combination with carboplatin and etoposide during the induction Cycles 1-4. Thereafter, participants will receive maintenance placebo until persistent radiographic PD, intolerable toxicity or withdrawal of consent, investigator's consideration, lost follow up, death ,study termination by the sponsor.whichever occurs first.
carboplatin + etoposide
Carboplatin and etoposide are background treatment.
Placebo
Placebo
Interventions
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AL3810
5mgQD, 7.5mgQD, 10mgQD
carboplatin + etoposide
Carboplatin and etoposide are background treatment.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, 18 \~75years of age
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed ES-SCLC
* No prior treatment for ES-SCLC
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function.
* Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.
Exclusion Criteria
* Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
* Uncontrolled hypertension.
18 Years
75 Years
ALL
No
Sponsors
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Haihe Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Baohui Han, M.D
Role: primary
Other Identifiers
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AL3810-301
Identifier Type: -
Identifier Source: org_study_id
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