Clinical trial NCT00100685: Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Official title: Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Metastases
Keywords: Kidney
renal
cancer
carcinoma
cell
metastatic
metastatic renal cell carcinoma
RCC
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-01-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: The proportion of patients with a confirmed tumor response at any time during the study
timeFrame: Any time during the study
Secondary outcomes:
measure: Time to disease progression
timeFrame: Up to 104 weeks
measure: Duration of tumor response
timeFrame: Up to 104 weeks
measure: Pharmacokinetics (PK) of M200
timeFrame: Day 0 through Study Termination
measure: Immunogenicity
timeFrame: Day 0 through Study Termination
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 70400
state: California
city: New York
country: United States
facility: Site Reference ID/Investigator# 70401
state: New York
city: Cleveland
country: United States
facility: Site Reference ID/Investigator# 70399
state: Ohio
Study officials:
affiliation: Abbott
name: Mihail Obrocea, MD
role: STUDY_DIRECTOR
References: