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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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