Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation

Metastatic Soft Tissue Sarcoma Clinical Trial

— SOURCE  

Official title:

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574716
• Other study ID #: MORAb-004-203-STS
• Secondary ID: 2012-001399-12
• Status: Completed
• Phase: Phase 2
• Start date: August 7, 2012
• Est. completion date: August 2, 2016

Study information

• Verified date: November 2016
• Source: Morphotek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 2, 2016
• Est. primary completion date: August 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Soft Tissue Sarcoma
• Sarcoma

Intervention

Drug:
• MORAb-004
IV, Days 1 and 8 of every cycle until disease progression
• Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
• Docetaxel
IV, Day 8 of every cycle until disease progression
• Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
• Docetaxel
IV, Day 8 of every cycle until disease progression
• Placebo

Locations

Country	Name	City	State
Australia	Canberra Hospital	Garran	Australian Capital Territory
Australia	Ashford Cancer Centre Research	Kurralta Park	South Australia
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia
Australia	Royal North Shore Hospital	St. Leonards	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Belgium	UZ Leuven Medical Oncology	Leuven
France	Institut Gustave Roussy	Villejuif
France	University of Claude Bernard	Villeurbanne
Italy	Istituto Ortopedico Rizzoli	Bologna
Netherlands	Leiden University Medical Center	Leiden
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	The University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Miami	Miami	Florida
United States	Mount Sinai Medical Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic - Rochester	Rochester	New York
United States	Washington University	Saint Louis	Missouri
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah
United States	Sarcoma Oncology Center	Santa Monica	California
United States	UCLA	Santa Monica	California
United States	Seattle Care Alliance	Seattle	Washington
United States	Siouxland Hematology-Oncology	Sioux City	Iowa
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Morphotek

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 2: Radiologic Progression-free Survival (PFS)	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.	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	Part 2: Symptomatic Progression-free Survival	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.	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	Part 2: Overall Survival (OS)	OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.	From date of first dose until date of death from any cause (up to approximately 3.5 years)
Secondary	Part 2: Overall Response Rate (ORR)	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.	From date of first dose until disease progression (up to approximately 3.5 years)
Secondary	Part 2: Radiologic Progression-free Survival Rate (PFR)	Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.	Weeks 12, 24, 48 and 52
Secondary	Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels		Up to approximately 3 years