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

Primary Purpose

Metastatic Soft Tissue Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MORAb-004
Gemcitabine
Docetaxel
Gemcitabine
Docetaxel
Placebo
Sponsored by
Morphotek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sarcoma Oncology Center
  • UCLA
  • Mayo Clinic Jacksonville
  • University of Miami
  • Moffitt Cancer Center
  • Northwestern Memorial Hospital
  • Siouxland Hematology-Oncology
  • Sidney Kimmel Comprehensive Cancer Center at John Hopkins
  • Dana-Farber Cancer Institute
  • University of Michigan Health System
  • Washington University
  • Mount Sinai Medical Center
  • Mayo Clinic - Rochester
  • The University of North Carolina at Chapel Hill
  • Oregon Health and Science University
  • Fox Chase Cancer Center
  • MD Anderson Cancer Center
  • Huntsman Cancer Institute at the University of Utah
  • Seattle Care Alliance
  • Canberra Hospital
  • Royal North Shore Hospital
  • Princess Alexandra Hospital
  • Ashford Cancer Centre Research
  • Sir Charles Gairdner Hospital
  • UZ Leuven Medical Oncology
  • Institut Gustave Roussy
  • University of Claude Bernard
  • Istituto Ortopedico Rizzoli
  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MORAb-004, gemcitabine, docetaxel

Placebo, gemcitabine, docetaxel

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels

Full Information

First Posted
April 4, 2012
Last Updated
August 1, 2019
Sponsor
Morphotek
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1. Study Identification

Unique Protocol Identification Number
NCT01574716
Brief Title
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 7, 2012 (Actual)
Primary Completion Date
August 11, 2015 (Actual)
Study Completion Date
August 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Morphotek

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MORAb-004, gemcitabine, docetaxel
Arm Type
Experimental
Arm Title
Placebo, gemcitabine, docetaxel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MORAb-004
Intervention Description
IV, Days 1 and 8 of every cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
IV, Days 1 and 8 of each cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV, Day 8 of every cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
IV, Days 1 and 8 of each cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
IV, Day 8 of every cycle until disease progression
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Part 2: Radiologic Progression-free Survival (PFS)
Description
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.
Time Frame
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 Measure Information:
Title
Part 2: Symptomatic Progression-free Survival
Description
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.
Time Frame
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)
Title
Part 2: Overall Survival (OS)
Description
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
Time Frame
From date of first dose until date of death from any cause (up to approximately 3.5 years)
Title
Part 2: Overall Response Rate (ORR)
Description
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.
Time Frame
From date of first dose until disease progression (up to approximately 3.5 years)
Title
Part 2: Radiologic Progression-free Survival Rate (PFR)
Description
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
Time Frame
Weeks 12, 24, 48 and 52
Title
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Time Frame
Up to approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
UCLA
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Siouxland Hematology-Oncology
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
2215
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Care Alliance
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UZ Leuven Medical Oncology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
University of Claude Bernard
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31034598
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.
Results Reference
derived

Learn more about this trial

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

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