To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
Study Details
Study Description
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EG017 81 subjects: Part Ia 21 subjects: A total of 4 dose groups of 6 mg/day, 12 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: Two dose groups of Part Ia, Once a day, each treatment cycle was administered for 28 days. |
Drug: EG017
According to the dosage group of the program, once a day.
|
Outcome Measures
Primary Outcome Measures
- Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs). [28 Days]
The CTCAE criteria will be used to assess adverse events on this trial.
- The effectiveness of EG017 in humans was evaluated by clinical benefit rate [24 Weeks]
The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female, 18-75 years old (stage Ia only) or 18-80 years old (stage Ib only);
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Expected survival ≥ 12 weeks (stage Ia only) or ≥ 24 weeks (stage Ib only);
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Subjects with ECOG score of physical state 0~1;
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Histologically confirmed recurrent or metastatic advanced breast cancer;
Exclusion Criteria:
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Those who have had a severe allergic reaction to any drug or its components in this study in the past;
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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);
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Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;
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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:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cancer Hospital of CAMS | Beijing | Benjing | China | 100020 |
| 2 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450000 |
| 3 | Hunan Cancer Hospital | Changsha | Hunan | China | 410000 |
Sponsors and Collaborators
- GeneScience Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EG017