A Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-Small Cell Lung Cancer With Bone Metastasis
NCT ID: NCT04325776
Last Updated: 2020-10-12
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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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2020-09-24
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AL2846+An analog of zoledronic acid injection
AL2846 capsules 150 mg given orally, once daily in 28-day cycle, an analog of zoledronic acid injection (5ml:0mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
AL2846
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
An analog of AL2846+ zoledronic acid injection
An analog of AL2846 capsules 0 mg given orally, once daily in 28-day cycle, zoledronic acid injection (5ml:4mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
Zoledronic Acid Injection
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.
Interventions
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AL2846
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
Zoledronic Acid Injection
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.
Eligibility Criteria
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Inclusion Criteria
3.Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.
4.Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.
5.EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.
Exclusion Criteria
3\. Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.
4\. Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.
5\. Has known to be allergic to the study drug or any of its excipients. 6. Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.
7\. Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.
8\. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
9\. Has spinal cord compression or mandibular osteonecrosis. 10.Has multiple factors that affect oral medications. 11.Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
12.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
13\. Has severe acute comorbidities before the first dose. 14. Has participated in other clinical trials within 4 weeks before the first dose.
15.According to the investigators' judgment.
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anhui Chest Hospital
Hefei, Anhui, China
Henan Cancer Hospital
Zhengzhou, Henan, China
China-Japan Union Hospital Of Jilin University
Changchun, Jilin, China
Jinzhou Central Hospital
Jinzhou, Liaoning, China
Shenyang Chest Hospital
Shenyang, Liaoning, China
Sir Run Run Shaw Hospital (SRRSH)
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Quzhou People's Hospital
Quzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AL2846-II-01
Identifier Type: -
Identifier Source: org_study_id
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