Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy

Study Overview
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Brief Summary
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This clinical trial is being conducted to determine tumor response and preliminary safety of a monoclonal antibody that specifically binds to a cell surface receptor (α5β1 integrin) that is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Official Title
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Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo

Conditions
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Melanoma, Metastases

Intervention / Treatment
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* Drug: M200 (volociximab) in Combination with Dacarbazine (DTIC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females of at least 18 years of age with stage IV or unresectable stage III non-ocular melanoma who may have received 0 to 2 prior regimens for metastatic disease with a biological therapy or immunotherapy (e.g., IL-2 or interferon-alfa). Measurable disease according to Response Criteria for Solid Tumors (RECIST). Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1. Estimated survival is greater or equal to 4 months. Negative pregnancy test (women of childbearing potential only). Pretreatment laboratory levels that meet specific criteria. Signed informed consent, including permission to use protected health information. Exclusion Criteria: Prior treatment with M200 or a5b1 inhibitors and murine or chimeric monoclonal antibodies. Prior treatment with DTIC, temozolomide, or other chemotherapeutic regimens. Known sensitivity to murine proteins or chimeric antibodies or other components of the product. Use of any investigational drug within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer). Systemic biologic, immunotherapy, and/or radiation therapy within 4 weeks of the first dose of M200. Documented central nervous system (CNS) tumor or CNS metastasis. History of thromboembolic events and bleeding disorders within the past year. Medical conditions that may be exacerbated by bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: M200 (volociximab) in Combination with Dacarbazine (DTIC)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with a confirmed tumor response at any time during the study. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression |  |  | 
| Duration of tumor response |  |  | 
| Pharmacokinetics (PK) |  |  | 
| Immunogenicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid tumors, Metastatic melanoma