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A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma

Phase 2
18 Years
Open (Enrolling)
Metastatic Soft Tissue Sarcoma

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Trial Information

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Primary Objective progression-free survival

Outcome Description:

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

Outcome Time Frame:

Length of Study

Safety Issue:


Principal Investigator

Susan C Weil, M.D., FACP

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

Related Keywords:

  • Metastatic Soft Tissue Sarcoma
  • Sarcoma



UCLALos Angeles, California  90095
Moffitt Cancer CenterTampa, Florida  33612
Sarcoma Oncology CenterSanta Monica, California  90403
University of Michigan Health SystemAnn Arbor, Michigan  
Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah  84112
Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, Maryland  21231
Seattle Care AllianceSeatlle, Washington  98109-1023