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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
Secondary ID [1] 0 0
2012-001399-12
Secondary ID [2] 0 0
MORAb-004-203-STS
Universal Trial Number (UTN)
Trial acronym
SOURCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MORAb-004
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Docetaxel

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

Outcomes
Primary outcome [1] 0 0
Part 2: Radiologic Progression-free Survival (PFS)
Timepoint [1] 0 0
From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
Secondary outcome [1] 0 0
Part 2: Symptomatic Progression-free Survival
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Part 2: Overall Survival (OS)
Timepoint [2] 0 0
From date of first dose until date of death from any cause (up to approximately 3.5 years)
Secondary outcome [3] 0 0
Part 2: Overall Response Rate (ORR)
Timepoint [3] 0 0
From date of first dose until disease progression (up to approximately 3.5 years)
Secondary outcome [4] 0 0
Part 2: Radiologic Progression-free Survival Rate (PFR)
Timepoint [4] 0 0
Weeks 12, 24, 48 and 52
Secondary outcome [5] 0 0
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Timepoint [5] 0 0
Up to approximately 3 years

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

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
Blinded (masking used)
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
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
7/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2016
Sample size
Target
Accrual to date
Final
209
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2065 - St. Leonards
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Leuven
Country [17] 0 0
France
State/province [17] 0 0
Villejuif
Country [18] 0 0
France
State/province [18] 0 0
Villeurbanne
Country [19] 0 0
Italy
State/province [19] 0 0
Bologna
Country [20] 0 0
Netherlands
State/province [20] 0 0
Leiden

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Morphotek
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01574716
Trial related presentations / publications
Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.
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/study/NCT01574716