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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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)
Secondary ID [1] 0 0
CDX011-04
Universal Trial Number (UTN)
Trial acronym
METRIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic gpNMB Over-expressing Triple Negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - CDX-011
Treatment: Drugs - Capecitabine

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.


Treatment: Drugs: CDX-011


Treatment: Drugs: Capecitabine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Evaluated every 6 - 9 weeks following treatment initiation
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Evaluated every 6 - 9 weeks following treatment initiation
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Evaluated every 6 - 9 weeks following treatment initiation
Secondary outcome [3] 0 0
Overall Survival
Timepoint [3] 0 0
During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.
Secondary outcome [4] 0 0
Adverse Events (AE)
Timepoint [4] 0 0
Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)
Secondary outcome [5] 0 0
Pharmacokinetics (PK)
Timepoint [5] 0 0
Following 1 dose of CDX-011.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/08/2018
Sample size
Target
Accrual to date
Final
327
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St. Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [3] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [4] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [5] 0 0
Townsville Hospital - Douglas
Recruitment hospital [6] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [7] 0 0
Western Hospital - Footscray
Recruitment hospital [8] 0 0
Joint Ludwig-Austin Dept of Medical Oncology - Heidelberg
Recruitment hospital [9] 0 0
Epworth Health Care - Richmond
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [4] 0 0
2076 - Wahroonga
Recruitment postcode(s) [5] 0 0
4814 - Douglas
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3121 - Richmond
Recruitment outside Australia
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Alabama
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Arizona
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Missouri
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North Carolina
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Washington
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Antwerpen
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Hainaut
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Paris
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Pierre Benite
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St Gregoire
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Halle
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Homberg
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Toscana
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Bologna
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Torino
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Asturias
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Barcelona
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Castellón
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Spain
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Communidad Delaware
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Spain
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Málaga
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Madrid
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Spain
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Valencia
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City Of London
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Devon
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East Sussex
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Glasgow City
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Lancashire
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London, City Of
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Nottinghamshire
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City of London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celldex Therapeutics
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01997333
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01997333