To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
NCT ID: NCT05673694
Last Updated: 2023-12-14
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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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2023-03-08
2026-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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EG017
70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
Part Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days.
EG017
According to the dosage group of the program, once a day.
Interventions
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EG017
According to the dosage group of the program, once a day.
Eligibility Criteria
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Inclusion Criteria
2. Expected survival ≥ 12 weeks;
3. Subjects with ECOG score of physical state 0\~1;
4. Histologically confirmed recurrent or metastatic advanced breast cancer;
Exclusion Criteria
2. Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);
3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:
18 Years
80 Years
FEMALE
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital of CAMS
Beijing, Benjing, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Binghe Xu, Doctor
Role: primary
Other Identifiers
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EG017
Identifier Type: -
Identifier Source: org_study_id