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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/NCT01574716
Registration number
NCT01574716
Ethics application status
Date submitted
4/04/2012
Date registered
10/04/2012
Date last updated
21/08/2019
Titles & IDs
Public title
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
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Scientific title
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
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Secondary ID [1]
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2012-001399-12
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Secondary ID [2]
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MORAb-004-203-STS
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Universal Trial Number (UTN)
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Trial acronym
SOURCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Soft Tissue Sarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MORAb-004
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo
Experimental: MORAb-004, gemcitabine, docetaxel -
Active Comparator: Placebo, gemcitabine, docetaxel -
Treatment: Drugs: MORAb-004
IV, Days 1 and 8 of every cycle until disease progression
Treatment: Drugs: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Treatment: Drugs: Docetaxel
IV, Day 8 of every cycle until disease progression
Treatment: Drugs: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Treatment: Drugs: Docetaxel
IV, Day 8 of every cycle until disease progression
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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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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Part 2: Radiologic Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
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Timepoint [1]
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From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
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Secondary outcome [1]
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Part 2: Symptomatic Progression-free Survival
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Assessment method [1]
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PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
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Timepoint [1]
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From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
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Secondary outcome [2]
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Part 2: Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
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Timepoint [2]
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From date of first dose until date of death from any cause (up to approximately 3.5 years)
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Secondary outcome [3]
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Part 2: Overall Response Rate (ORR)
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Assessment method [3]
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ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
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Timepoint [3]
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From date of first dose until disease progression (up to approximately 3.5 years)
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Secondary outcome [4]
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Part 2: Radiologic Progression-free Survival Rate (PFR)
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Assessment method [4]
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Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
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Timepoint [4]
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Weeks 12, 24, 48 and 52
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Secondary outcome [5]
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Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
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Assessment method [5]
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Timepoint [5]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
- Be at least 18 years of age
- Be surgically sterile or consent to use a medically acceptable method of contraception
throughout the study period
- Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study
subgrouped
- Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for
mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance
therapies will not be considered as regimens in the metastatic setting for the
purposes of this protocol. Prior anthracycline-based regimen is allowable but not
required. Subjects with extra-skeletal small round blue cell sarcomas, including
rhabdomyosarcomas, must have exhausted or be intolerant of standard first line
anthracycline-based chemotherapy.)
- Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study
entry and have radiologically documented disease progression greater than or equal to
a 10% increase in the sum of the longest diameters of target lesions present within 6
months prior to randomization
- Have tumor tissue available for TEM-1 biomarker studies
- Be willing and able to provide written informed consent
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Minimum age
18
Years
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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
- Have received more than 2 prior systemic treatment regimens for mSTS
- Have received either gemcitabine or docetaxel in any previous treatment for mSTS
(regardless of the line of treatment)
- Have a diagnosis of primary bone sarcoma of any histological type.
- Have a history of clinically significant heart disease, or clinically significant
arrhythmia on ECG within the past 6 months
- Have a history of allergic reaction to prior monoclonal antibody or biologic agent
- Have received previous treatment with MORAb-004 (anti-TEM-1)
- Have a medical condition with a high risk of bleeding (e.g., a known bleeding
disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent
(within past 6 months) history of a significant bleeding event
- Have undergone major surgical procedures or open biopsy, have significant traumatic
injury within 30 days prior to the first date of study treatment, or have major
surgical procedures anticipated during the study
- Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone
fracture
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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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Type of endpoint/s
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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
7/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2016
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Sample size
Target
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Accrual to date
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Final
209
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [4]
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Ashford Cancer Centre Research - Kurralta Park
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Recruitment hospital [5]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2065 - St. Leonards
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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5037 - Kurralta Park
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Recruitment postcode(s) [5]
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6009 - Perth
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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Iowa
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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Missouri
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New York
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North Carolina
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Oregon
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Pennsylvania
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Texas
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Utah
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Washington
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Country [16]
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Belgium
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Leuven
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France
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Villejuif
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France
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Villeurbanne
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Italy
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Bologna
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Netherlands
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Leiden
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Morphotek
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being done to see if MORAb-004 increases the effectiveness of the
chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01574716
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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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Address
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01574716
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