Clinical trial · Interventional
Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemotherapy
Phase II Open-Label Study of Volociximab in Combination With DTIC in Patients With Metastatic Melanoma Not Previously Treated With Chemo
NCT00099970CI-TRIAL-00001636completedPhase 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) that 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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M200 (volociximab) in Combination with Dacarbazine (DTIC) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients with a confirmed tumor response at any time during the study.
Secondary outcomes (4)
- measure
- Time to disease progression
- measure
- Duration of tumor response
- measure
- Pharmacokinetics (PK)
- measure
- Immunogenicity
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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.