NCT01456585

Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

Phase 1 Study of Preoperative Gemcitabine Plus CP-870,893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patient With Newly Diagnosed Resectable Pancreatic Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893 will be pre-op and 3 doses post-op.

Detailed description

This is an open-label single-arm,phase 1, trial. Ten patients with newly diagnosed resectable pancreatic carcinoma will receive gemcitabine and CP-870,893 two weeks prior to surgical resection and subsequently during standard-of-care adjuvant chemoradiation therapy (at which time CP-870,893 will be given on day 3 of each of three 28-day cycles of gemcitabine). Previously established doses of each agent will be used and each given by IV infusion.

Conditions

• Adenocarcinoma Pancreas

Interventions

Type	Name	Description
OTHER	Gemcitabine
DRUG	CP-870,893

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-10-21
• Last updated: 2018-08-27

Locations

1 site across 1 country: United States