NCT00735917

Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib). II. To determine the adverse events of this drug in these patients. SECONDARY OBJECTIVES: I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients. OUTLINE: Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.

Conditions

• Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	saracatinib	Given PO
OTHER	pharmacogenomic studies	Optional correlative studies
OTHER	pharmacological study	Optional correlative studies
PROCEDURE	positron emission tomography	Optional correlative studies
RADIATION	fludeoxyglucose F 18	Optional correlative studies
OTHER	laboratory biomarker analysis	Optional correlative studies

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-04-01
• Completion: 2012-10-01
• First posted: 2008-08-15
• Last updated: 2019-04-02
• Results posted: 2013-12-05

Locations

9 sites across 3 countries: United States, Australia, Singapore