To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04550949|
Recruitment Status : Unknown
Verified September 2020 by Qilu Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : September 16, 2020
Last Update Posted : September 22, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases||Drug: QL1206 Drug: Xgeva||Phase 3|
This is A multi-center, randomized, double-blind, comparative clinical trial.
The primary objective is to evaluate whether the clinical efficacy of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.
The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1206 and Xgeva® are similar in patients with bone metastases from solid tumors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Randomized, Double-blind, Comparative Study to Evaluate the Clinical Efficacy and Safety of QL1206 and Xgeva® in Patients With Bone Metastases From Solid Tumors|
|Actual Study Start Date :||April 26, 2019|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||June 10, 2022|
QL1206 injection(120mg)was administered subcutaneously once every 4 weeks for a maximum of 13 consecutive doses throughout the trial, according to the investigator's assessment.
The active ingredient of QL1206 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
Other Name: recombinant human anti-RANKL monoclonal antibody injection
Active Comparator: Xgeva®
Xgeva® injection(120mg) was administered subcutaneously every 4 weeks for a maximum of 13 cumulative doses throughout the trial,according to the investigator's assessment.
The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
Other Name: Denosumab Injection
- uNTx/uCr [ Time Frame: from baseline to week 13 ]Compare QL1206 and Xgeva® for percentage change in bone conversion index (BTM) - urinary type I collagen cross-linked peptide (uNTx) adjusted for urinary creatinine (uCr) in Chinese subjects with solid tumor bone metastasis (uNTx/uCr from baseline to week 13)
- uNTx/uCr [ Time Frame: from baseline to weeks 25 and 53 ]Compare the percentage change in QL1206 and Xgeva® for bone conversion indicator uNTx/uCr among subjects with solid tumor metastasis (from baseline to weeks 25 and 53).
- S-BALP [ Time Frame: from baseline to weeks 13, 25, and 53 ]Compare the changes of bone specific alkaline phosphatase (S-BALP) from baseline to weeks 13, 25, and 53.
- SRE [ Time Frame: from baseline to weeks 53 ]SRE occurrence
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Through the explanation of the researcher or the researcher's authorized representative, the subject has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent;
- Radiologic evidence (i.e. X-ray examination, computed tomography CT, magnetic resonance imaging MRI, positron emission computed tomography PET-CT) in grade III grade A hospitals has been documented (within 3 months prior to study administration) that there is at least one bone metastasis;
- The ECOG score was 0-2.
- Chinese adults with solid tumor confirmed by histological or cytological examination (age ≥18 years, ≤80 years).
- Patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug (those who had previously used an intravenous or oral bisphosphonates but had a continuous use time of less than 3 months and more than 5 years before the administration of this study could be included in the study).
- Previous treatment with denosumab.
- Previous or ongoing osteomyelitis or osteonecrosis of the jaw ONJ , active dental disease or jaw bone disease requiring oral surgery, the wound of dental operation or oral surgery has not healed well, or invasive dental operation has been planned during the study period.
- Plan to perform radiotherapy or or bone surgery. Patients who received radiotherapy within one month before the first study drug administration were not allowed to be included.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04550949
|Beijing Cancer Hospital||Recruiting|
|Beijing, Beijing, China, 100037|
|Contact: huiping LI, professor 010-88140650 email@example.com|
|Sun Yat-sen University Cancer Hospital||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: li ZHANG, professor 020-87342288 firstname.lastname@example.org|
|Responsible Party:||Qilu Pharmaceutical Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||September 16, 2020 Key Record Dates|
|Last Update Posted:||September 22, 2020|
|Last Verified:||September 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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