Clinical trial NCT01574716: Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Official title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Soft Tissue Sarcoma
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Part 2: Radiologic Progression-free Survival (PFS)
timeFrame: 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 outcomes:
measure: Part 2: Symptomatic Progression-free Survival
timeFrame: 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)
measure: Part 2: Overall Survival (OS)
timeFrame: From date of first dose until date of death from any cause (up to approximately 3.5 years)
measure: Part 2: Overall Response Rate (ORR)
timeFrame: From date of first dose until disease progression (up to approximately 3.5 years)
measure: Part 2: Radiologic Progression-free Survival Rate (PFR)
timeFrame: Weeks 12, 24, 48 and 52
measure: Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
city: Santa Monica
country: United States
facility: UCLA
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology
state: Iowa
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Care Alliance
state: Washington
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leuven Medical Oncology
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Villeurbanne
country: France
facility: University of Claude Bernard
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
References:
citation: 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.