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

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ClinicalTrials.gov Identifier: NCT01574716
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Morphotek

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

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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 With MORAb-004 in Metastatic Soft Tissue Sarcoma
Actual Study Start Date : August 7, 2012
Actual Primary Completion Date : August 11, 2015
Actual Study Completion Date : August 2, 2016

Resource links provided by the National Library of Medicine


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. Part 2: Radiologic Progression-free Survival (PFS) [ 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) ]
    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 :
  1. Part 2: Symptomatic Progression-free Survival [ 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) ]
    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.

  2. Part 2: Overall Survival (OS) [ Time Frame: From date of first dose until date of death from any cause (up to approximately 3.5 years) ]
    OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.

  3. Part 2: Overall Response Rate (ORR) [ Time Frame: From date of first dose until disease progression (up to approximately 3.5 years) ]
    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.

  4. Part 2: Radiologic Progression-free Survival Rate (PFR) [ Time Frame: Weeks 12, 24, 48 and 52 ]
    Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.

  5. Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels [ Time Frame: Up to approximately 3 years ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01574716


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Sponsors and Collaborators
Morphotek

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Responsible Party: Morphotek
ClinicalTrials.gov 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
Results First Posted: August 21, 2019
Last Update Posted: August 21, 2019
Last Verified: November 2016
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
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