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To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550949
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone Metastases Drug: QL1206 Drug: Xgeva Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: QL1206
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.
Drug: QL1206
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.
Drug: Xgeva
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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
Criteria

Inclusion Criteria:

  1. 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;
  2. 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;
  3. The ECOG score was 0-2.
  4. Chinese adults with solid tumor confirmed by histological or cytological examination (age ≥18 years, ≤80 years).

Exclusion Criteria:

  1. 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).
  2. Previous treatment with denosumab.
  3. 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.
  4. 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.

Information from the National Library of Medicine

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


Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: huiping LI, professor    010-88140650    huipingli2012@hotmail.com   
China, Guangdong
Sun Yat-sen University Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: li ZHANG, professor    020-87342288    zhangli@sysucc.org.cn   
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04550949    
Other Study ID Numbers: QL1206-003
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Denosumab
Physiological Effects of Drugs
Bone Density Conservation Agents