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The study is being conducted to evaluate the efficacy, and safety of SHR-2017 Injection in Patients with Bone Metastases from Solid Tumors. To explore the reasonable dosage of SHR-2017 Injection for Bone Metastases from Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR-2017、Denosumab placebo | Experimental |
| |
| Treatment group B: SHR-2017、Denosumab placebo | Experimental |
| |
| Treatment group C: Denosumab;SHR-2017 placebo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2017、Denosumab placebo | Drug | SHR-2017; high dose ;Denosumab placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to pain relief | Analgesic evaluation using NRS scores | randomization to 48 weeks after administration |
| percentage of change in the bone turnover marker urine N-telopeptide corrected for urine creatinine (uNTx/Cr) from baseline to study week 13 | randomization to 13 weeks after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first on-study SRE (defined as pathologic fracture, radiation or surgery to bone, or spinalcord compression). | randomization to 72 weeks after administration | |
| Change from Baseline in the daily average pain intensity in the index bonemetastasis cancer pain site. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Zhao | Contact | +0518-82342973 | qian.zhao@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| SHR-2017、Denosumab placebo | Drug | SHR-2017; low dose ;Denosumab placebo |
|
| Denosumab;SHR-2017 placebo | Drug | Denosumab;SHR-2017 placebo |
|
| randomization to 48 weeks after administration |
| Change from Baseline in the daily worst pain intensity in the index bonemetastasis cancer pain site. | randomization to 48 weeks after administration |
| Response as defined by a ≥2 point reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site | randomization to 48 weeks after administration |
| Average daily total opioid consumption (in mg of morphine equivalent doses) | randomization to 48 weeks after administration |