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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01574716
First received: April 4, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Metastatic Soft Tissue Sarcoma
Drug: MORAb-004
Drug: Gemcitabine
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Primary Objective progression-free survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
    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:
  • Secondary Objective Overall Survival [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]

    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.


  • - Overall Response Rate (ORR) [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
    based on RECIST v 1.1

  • - PFS rate (PRF) [ Time Frame: at 12, 24 and 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574716

  Show 29 Study Locations
Sponsors and Collaborators
Morphotek
Investigators
Principal Investigator: Robert G Maki, M.D., FACP Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01574716     History of Changes
Other Study ID Numbers: MORAb-004-203-STS, 2012-001399-12
Study First Received: April 4, 2012
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014