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Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma, Metastases

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Trial Information

Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma

Inclusion 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The proportion of patients with a confirmed tumor response at any time during the study

Outcome Time Frame:

Any time during the study

Safety Issue:


Principal Investigator

Mihail Obrocea, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

December 2007

Related Keywords:

  • Renal Cell Carcinoma
  • Metastases
  • Kidney
  • renal
  • cancer
  • carcinoma
  • cell
  • metastatic
  • metastatic renal cell carcinoma
  • RCC
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplasm Metastasis



Site Reference ID/Investigator# 70400 Los Angeles, California  90095
Site Reference ID/Investigator# 70401 New York, New York  10021
Site Reference ID/Investigator# 70399 Cleveland, Ohio  44195