Phase 1
Completed N=22
A Study On An Immunostimulant Antibody In Combination With Chemotherapy For Advanced Cancer Of The Pancreas
Source: ClinicalTrials.gov NCT00711191 ↗Enrolled (actual)
22
Serious AEs
40.9%
Results posted
Jun 2012
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicities (DLTs) — 0; 0; 1 participants
Summary
This study aims to seek evidence that activation of certain cells of the immune system will be safe and well tolerated in combination with cytotoxic chemotherapy. Preliminary evidence of clinical anti-tumor activity will be sought.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 1 | — |
| SECONDARY Percentage of Participants With Objective Tumor Response According to Response Evaluation Criteria in Solid Tumors (RECIST) |
33.3; 16.7; 7.7 | — |
| SECONDARY Overall Survival (OS) |
8.4 | — |
| SECONDARY Progression Free Survival (PFS) |
5.3 | — |
| SECONDARY Time to Progression |
— | — |
| SECONDARY Maximum Serum Concentration (Cmax) |
— | — |
| SECONDARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
— | — |
| SECONDARY Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Pre-dose Concentration (CYTO0), Maximum Concentration (CTYOMAX) |
— | — |
| SECONDARY Change (Pre-dose to Post-dose) in Plasma Cytokine Concentrations: Time of Maximum Concentration (TCYTOMAX) |
— | — |
| SECONDARY Total and Neutralizing Human Antihuman Antibody (HAHA) Titer |
— | — |
| SECONDARY Change (Pre-dose to Post-dose) in Bone Marrow Derived Cells (B Cell) Surface Markers: CD54, CD23, CD40, CD86, and Human Leukocyte Antigen (HLA-DR) |
— | — |
| SECONDARY 18-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging (MTD Expansion Cohort) |
— | — |
| SECONDARY Carbohydrate Antigen 19-9 (CA 19-9) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 1st-line surgically incurable cancer of the pancreas
- ECOG(Eastern Cooperative Oncology Group) performance status 0-1
Exclusion Criteria
- Previous systemic therapy for pancreas cancer
- History of cancer-associated blood clots
- History of autoimmune disease
Data sourced from ClinicalTrials.gov (NCT00711191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.