Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)

Abbott

Status and phase: Terminated; Phase 2

Conditions: Metastases; Renal Cell Carcinoma

Treatments: Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00100685

M200-1204

Details and patient eligibility

About

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) and is required for the establishment of new blood vessels during tumor growth, a process known as angiogenesis.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Males and females of at least 18 years of age with metastatic RCC of predominantly clear cell histology who have received 0 to 2 prior treatment regimens for metastatic disease.
• Measurable disease according to Response Criteria for Solid Tumors.
• Negative pregnancy test (women of childbearing potential only).
• Pretreatment laboratory levels that meet specific criteria.
• Signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations
• Patients must have failed at least one approved or investigational tyrosine kinase inhibitor (TKI).

Exclusion Criteria

• Any of the following histologies of RCC: papillary, chromophobe, collecting duct, or unclassified.
• 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 chemotherapy, immunotherapy, radiation therapy, or monoclonal antibody therapy within 4 weeks of M200 administration.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Arm 1

Experimental group

Description:

Volociximab administered intravenously at a dose of 10 mg/kg qowk

Treatment:

Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)

Arm 2

Experimental group

Description:

Volociximab administered intravenously at a dose of 15 mg/kg qwk

Treatment:

Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)