Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01335009
Recruitment Status : Active, not recruiting
First Posted : April 13, 2011
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):

March 14, 2011
April 13, 2011
March 7, 2017
May 16, 2011
December 2, 2013   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS) rate based on RECIST [ Time Frame: after 80 subjects complete 24 weeks of treatment ]
Evaluate the rate of PFS at 24 weeks for two dose levels of MORAb-004 based on RECIST (radiographic measure of tumors)
Same as current
Complete list of historical versions of study NCT01335009 on Archive Site
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Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma

This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.

80+ subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression.

Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy.

Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).

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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Melanoma
Biological: MORAb-004 (monoclonal antibody)
Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs.
  • Experimental: MORAb-004, 2 mg/kg
    Biologic (monoclonal antibody)
    Intervention: Biological: MORAb-004 (monoclonal antibody)
  • Experimental: MORAb-004, 4 mg/kg
    Biologic (monoclonal antibody)
    Intervention: Biological: MORAb-004 (monoclonal antibody)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
December 2017
December 2, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Germany,   United Kingdom,   United States
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February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP