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Sponsor R & D Strategy Adjustment
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This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR9549 dose escalation and expansion(s) | Experimental | Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR9549 | Drug | If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | to determine DLT in order to assess the tolerability of SHR9549 | baseline through 28 days |
| Maximum Tolerated Dose (MTD) | to determine MTD in order to assess the tolerability of SHR9549 | baseline through 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals | baseline through 12 weeks |
| Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 307th Hospital of Military Chinese People's Liberation Army | Beijing | Beijing Municipality | 100071 | China |
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Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
| baseline through 12 weeks |
| overall response rate (ORR) | Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1) | every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months |
| progression free survival (PFS) | Antitumour activity evaluation by following up patients' progression and survival | every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months |
| Incidence of Treatment-Emergent Adverse Events | to assess the safety of SHR9549 | baseline through 30 days after study completion |