Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation. (SOURCE)
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/1/2016 |
Start Date: | May 2012 |
End Date: | August 2016 |
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma
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.
chemotherapies gemcitabine and docetaxel in people with 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
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
We found this trial at
19
sites
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
Click here to add this to my saved trials
University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Click here to add this to my saved trials
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
Click here to add this to my saved trials
1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials