Spots Global Cancer Trial Database for Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients

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Trial Identification

Brief Title: Combination Therapy of L19IL2 and Gemcitabine in Advanced Pancreatic Cancer Patients

Official Title: Phase I Study of the Tumor-targeting Human L19IL2 Monoclonal Antibody-cytokine Fusion Protein in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer

Study ID: NCT01198522

Conditions

Pancreatic Cancer Patients Diagnosed With Locally Advanced or Metastatic Pancreatic Cancer Not Amenable to Curative Surgical Resection

Interventions

L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine

Study Description

Brief 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).

Detailed Description: