A Phase I/II Study of Gleevec® Combined With Panitumumab (Vectibix®) in Patients Prescreened for C-kit/PDGFr Activated Pathways Using a Proteomic Based Assay (NITMEC)

NCT00867334 Phase 1/Phase 2 COMPLETED Results posted

The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in combination with panitumumab for the treatment of stage IV colorectal cancer that has spread to the liver. It will also assess the whether imatinib mesylate, either alone or in combination with panitumumab, is effective in treating this type of cancer. In addition, the study will evaluate the feasibility of a predefined lab score and whether it can predict which patients will respond to treatment with imatinib mesylate.

Details

Lead sponsor	Inova Health Care Services
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	10
Start date	2009-06
Completion	2011-08

Conditions

• Colorectal Neoplasm
• Colorectal Cancer

Interventions

• Imatinib mesylate and panitumumab
• Standard-of-care treatment with panitumumab

Primary outcomes

• Number of Patients With Adverse Events — From consent up until 4 weeks after patient has stopped study participation
  Information about all adverse events, whether volunteered by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected and recorded.

Countries

United States