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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01335009
First received: March 14, 2011
Last updated: July 15, 2014
Last verified: July 2014

March 14, 2011
July 15, 2014
April 2011
March 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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2014
March 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Germany,   United Kingdom
 
NCT01335009
MORAb-004-201MEL
No
Morphotek
Morphotek
Not Provided
Not Provided
Morphotek
July 2014

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