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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT01335009
First received: March 14, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition Intervention Phase
Metastatic Melanoma
 Biological: MORAb-004 (monoclonal antibody)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Morphotek:

Primary Outcome Measures:
  • 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)


Enrollment: 81
Study Start Date: April 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MORAb-004, 2 mg/kg
Biologic (monoclonal antibody)
 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, 4 mg/kg
Biologic (monoclonal antibody)
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335009

  Show 29 Study Locations
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT01335009     History of Changes
Other Study ID Numbers: MORAb-004-201MEL
Study First Received: March 14, 2011
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Australia: National Health and Medical Research Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Morphotek:
melanoma
malignant
metastatic

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013