NCT00530192

Molecular Profiling Protocol (SCRI-CA-001)

A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Scottsdale Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter pilot study in patients with advanced solid tumors. The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on. To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

Conditions

• Refractory Cancer

Interventions

Type	Name	Description
OTHER	Treatment based on Molecular Profiling	Treatment with commercially available treatments (per package insert instructions)

Timeline

• Start date: 2006-09-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-09-17
• Last updated: 2009-07-10

Locations

9 sites across 1 country: United States