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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01997333
Registration number
NCT01997333
Ethics application status
Date submitted
18/11/2013
Date registered
28/11/2013
Date last updated
8/03/2019
Titles & IDs
Public title
Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer
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Scientific title
A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)
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Secondary ID [1]
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CDX011-04
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Universal Trial Number (UTN)
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Trial acronym
METRIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Active comparator: Capecitabine - Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.
Experimental: Drug: CDX-011 - CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.
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Timepoint [1]
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Evaluated every 6 - 9 weeks following treatment initiation
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
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Timepoint [1]
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Evaluated every 6 - 9 weeks following treatment initiation
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.
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Timepoint [2]
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Evaluated every 6 - 9 weeks following treatment initiation
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Secondary outcome [3]
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Overall Survival
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Assessment method [3]
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Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
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Timepoint [3]
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During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
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Secondary outcome [4]
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Adverse Events (AE)
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Assessment method [4]
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The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.
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Timepoint [4]
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Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
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Secondary outcome [5]
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Pharmacokinetics (PK)
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Assessment method [5]
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Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.
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Timepoint [5]
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Following 1 dose of CDX-011.
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Eligibility
Key inclusion criteria
Among other criteria, patients must meet all of the following conditions to be eligible for the study:
1. Diagnosed with metastatic (i.e., cancer that has spread) TNBC
* minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
* HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
3. Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
6. ECOG performance status of 0 - 1.
7. Adequate bone marrow, liver and renal function.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion:
Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
4. Significant cardiovascular disease.
5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
7. Chronic use of systemic corticosteroids.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
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Actual
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Date of last data collection
Anticipated
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Actual
7/08/2018
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Sample size
Target
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Accrual to date
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Final
327
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St. Vincents Hospital Sydney - Darlinghurst
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Macquarie University - Macquarie Park
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The Tweed Hospital - Tweed Heads
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Sydney Adventist Hospital - Wahroonga
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Townsville Hospital - Douglas
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Box Hill Hospital - Box Hill
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Western Hospital - Footscray
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Joint Ludwig-Austin Dept of Medical Oncology - Heidelberg
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Epworth Health Care - Richmond
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2010 - Darlinghurst
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2109 - Macquarie Park
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2485 - Tweed Heads
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2076 - Wahroonga
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4814 - Douglas
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3128 - Box Hill
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3011 - Footscray
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3084 - Heidelberg
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3121 - Richmond
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Celldex Therapeutics
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
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Trial website
https://clinicaltrials.gov/study/NCT01997333
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/33/NCT01997333/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/33/NCT01997333/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01997333
Download to PDF