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A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma

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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