Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients
Summary
Systemic treatment for advanced, non-resectable pancreatic cancer still having minimal impact on the survival of patients. Even with the application of more potent gemcitabine-based regimens, survival of more than 1 year is uncommon for advanced disease. Accordingly, there is substantial unmet needs for the improvement of treatment options. The combination and simultaneous application of tumor-targeted L19IL2 with gemcitabine could result in improved anti-cancer efficacy, based on preliminary clinical and strong preclinical data. The primary purpose of this Phase I study is to define a safe and potentially more active treatment regimen of L19IL2 (escalating doses) combined with gemcitabine for advanced pancreatic cancer patients. Also, early signs of anticancer responses of the L19IL2/gemcitabine regimen will be assessed and compared to historical controls (gemcitabine monotherapy).
Timeline
- Start
- 2007-06
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darleukin | Protein / enzyme biologic | 10 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 15 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 22.5 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 30 iu | Intravenous |
| Subject | Darleukin | Protein / enzyme biologic | 37.5 iu | Intravenous |
| Subject | Gemcitabine | Small molecule | 800 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
Indications
No indication recorded.