Clinical trial · Interventional
A Study of Volociximab in Combination With Gemcitabine in Metastatic Pancreatic Cancer
Phase 2 Open-Label Study of Volociximab (M200) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Cancer Not Previously Treated With Chemotherapy
NCT00401570CI-TRIAL-00009192completedPhase 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 (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Volociximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Volociximab (10 mg/kg every other week (qowk)) and Gemcitabine
- interventionNames
- Drug: Volociximab
- Drug: Gemcitabine
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Volociximab (15 mg/kg weekly (qwk)) and Gemcitabine
- interventionNames
- Drug: Volociximab
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- The proportion of patients, in each dose cohort, with a confirmed tumor response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, 18 years of age or older. * Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. * May have received prior immunotherapy (including monoclonal antibodies) or vaccine therapies. * Measurable disease, according to RECIST criteria. * Negative pregnancy test (women of childbearing potential only). * Pretreatment laboratory levels that meet specific criteria. Exclusion Criteria: * Prior treatment with Volociximab (M200) or inhibitors of α5β1 integrin (antibodies or small molecules) or gemcitabine and other chemotherapeutic regimens. * Known hypersensitivity 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). * Monoclonal antibody therapy within 4 weeks of the first dose of Volociximab. * Central Nervous System (CNS) tumor or metastasis. * History of 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.