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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01574716
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : November 30, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Metastatic Soft Tissue Sarcoma Drug: MORAb-004 Drug: Gemcitabine Drug: Docetaxel Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma
Study Start Date : May 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: MORAb-004, gemcitabine, docetaxel Drug: MORAb-004
IV, Days 1 and 8 of every cycle until disease progression
Drug: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Drug: Docetaxel
IV, Day 8 of every cycle until disease progression
Active Comparator: Placebo, gemcitabine, docetaxel Drug: Gemcitabine
IV, Days 1 and 8 of each cycle until disease progression
Drug: Docetaxel
IV, Day 8 of every cycle until disease progression
Drug: Placebo

Primary Outcome Measures :
  1. Primary Objective progression-free survival [ Time Frame: Length of study ]
    To evaluate the progression-free survival (PFS) of subjects treated with the combination of gemcitabine/docetaxel (G/D) plus MORAb-004 versus G/D plus placebo in subjects with metastatic soft tissue sarcoma

Secondary Outcome Measures :
  1. Secondary Objective Overall Survival [ Time Frame: Length of study ]

    To assess other clinical parameters

    - Overall Survival (OS)

    To assess the safety and tolerability of MORAb-004 in combination with gemcitabine and docetaxel

    To correlate the pattern of biomarker expression (tumor endothelial marker-1 [TEM-1] and members of the TEM-1 signaling pathway) in tumor samples with observed clinical parameters, including PFS, OS and ORR.

  2. Overall Response Rate (ORR) [ Time Frame: Length of study ]
    based on RECIST v 1.1

  3. PFS rate (PRF) [ Time Frame: at 12, 24 and 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01574716

  Show 29 Study Locations
Sponsors and Collaborators
Principal Investigator: Robert G Maki, M.D., FACP Icahn School of Medicine at Mount Sinai

Responsible Party: Morphotek Identifier: NCT01574716     History of Changes
Other Study ID Numbers: MORAb-004-203-STS
2012-001399-12 ( EudraCT Number )
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators