AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
Zoledronic acid is a bisphosphonate drug that has a strong inhibition of bone resorption and a potential to promote bone formation, and can be used for bone metastasis caused by malignant tumors.
Anhui Chest Hospital
Hefei, Anhui, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGChina-Japan Union Hospital Of Jilin University
Changchun, Jilin, China
The time when the first bone-related event (SRE) occurred
The time from the randomization to the first occurrence of any meeting of bone-related event criteria.
Time frame: up to 96 weeks
Overall survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 96 weeks
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.
Time frame: up to 96 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved complete or partial remission to disease progression.
Time frame: up to 96 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Effectiveness of improving average daily pain intensity on week 8 and 16 (Refer to Brief pain inventory (BPI) and the Verbal rating scale (VRS)
Referring to Brief pain inventory (BPI) and Verbal rating scale (VRS), the percentage of improvement in the average intensity of pain confirmed at week 8 and week 16 compared to the previous average intensity.
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Jinzhou Central Hospital
Jinzhou, Liaoning, China
RECRUITINGShenyang Chest Hospital
Shenyang, Liaoning, China
RECRUITINGSir Run Run Shaw Hospital (SRRSH)
Hangzhou, Zhejiang, China
RECRUITINGThe First Hospital of Jiaxing
Jiaxing, Zhejiang, China
NOT_YET_RECRUITINGQuzhou People's Hospital
Quzhou, Zhejiang, China
RECRUITINGTime frame: on 8 and 16 week
Biomarkers
Relationship between drug efficacy and related biomarkers such as C-Met, FGFR, c-Kit, RET.
Time frame: up to 96 weeks