Clinical trial · Interventional
Study of M200 (Volociximab) in Patients With Metastatic Renal Cell Carcinoma (RCC)
Phase 2 Open-Label Study of Volociximab (M200) in Patients With Metastatic Renal Cell Carcinoma
NCT00100685CI-TRIAL-00006797terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases | — | UNRESOLVED | — |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Volociximab (anti-α5β1 integrin monoclonal antibody) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Volociximab administered intravenously at a dose of 10 mg/kg qowk
- interventionNames
- Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Volociximab administered intravenously at a dose of 15 mg/kg qwk
- interventionNames
- Drug: Volociximab (anti-α5β1 integrin monoclonal antibody)
Primary outcomes (1)
- measure
- The proportion of patients with a confirmed tumor response at any time during the study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.