A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
18 Years
N/A
Both
Metastatic Melanoma
Trial Information
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma
MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein,
which is expressed on cells involved in tumor vasculature. Studies have found endosialin to
play a key role in tumor growth and neovessel formation in numerous cancer types including
melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially
useful anti-cancer agent. This clinical trial is being performed to determine the efficacy
of MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to
establish serum pharmacokinetics and pharmacodynamics of the antibody.
Inclusion Criteria:
- Histologically confirmed diagnosis of metastatic melanoma
- At least one prior line of systemic treatment with confirmed progression of disease
- Measurable disease, as defined by RECIST, assessed within 4 wks prior to study entry
- At least 3 week interval between first infusion of test article and most recent prior
systemic anticancer therapy
- ECOG Performance Status of 0 or 1
Exclusion Criteria:
- Evidence of other active malignancy requiring treatment within the last 5 years
(other than basal cell or squamous cell carcinoma of the skin), or active brain
metastasis
- Clinically significant heart disease (Congestive heart failure of NYHA Class 3 or 4,
angina not well controlled by medication, or myocardial infarction within 6 mos.), or
ECGs demonstrating clinically significant arrhythmias
- Brain metastasis
- Known allergic reaction to a prior monoclonal antibody therapy
- Previous treatment with MORAb-004
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS) rate based on RECIST
Outcome Description:
Evaluate the rate of PFS at 24 weeks for two dose levels of MORAb-004 based on RECIST (radiographic measure of tumors)
Outcome Time Frame:
after 80 subjects complete 24 weeks of treatment
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
MORAb-004-201MEL
NCT ID:
NCT01335009
Start Date:
April 2011
Completion Date:
December 2013
Related Keywords:
- Metastatic Melanoma
- melanoma
- malignant
- metastatic
- Melanoma
Name | Location |
|---|---|
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| University of California Los Angeles | Los Angeles, California 90095-6951 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Yale University | New Haven, Connecticut 06520 |
| Oncology Specialists, SC | Park Ridge, Illinois 60068 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| The University of Chicago | Chicago, Illinois 60637 |
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina 27599 |
| The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
| University of Utah Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| St. Luke'S Hospital & Health Network | Bethlehem, Pennsylvania 18015 |
| New York University Cancer Institute | New York, New York 10016 |
| Pinnacle Oncology | Scottsdale, Arizona 85258 |
| University of Colorado Cancer Center, Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
| University of Iowa Hospital | Iowa City, Iowa 52242 |
| Atlantic Health | Morristown, New Jersey 07962 |
| Memorial Sloane-Kettering Cancer Center | New York, New York 10065 |
