A Study of Therapy Selected by Molecular/Metabolic Profiling in Patients With Previously Treated Metastatic Pancreatic Cancer

NCT01196247 | Completed Phase 2

• 1 other identifier: SU2C-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is selecting second line therapy for patients with pancreatic cancer using molecular profiling will improve 1 year survival.

Conditions

Previously Treated Metastatic Pancreatic Cancer

Keywords

pancreatic cancer; molecular profiling; SU2C; Second line therapy; Stage 4

Outcome Measures

Primary Outcomes (1)

• Determine the percent of patients who are alive at one year

  Goal is to improve the one year survival (from start of first-line therapy for metastatic disease) to 60%

  One year

Interventions

Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank DRUG

FDA approved drugs as indicated by molecular profiling

Also known as: FDA approved drugs as indicated by molecular profiling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• metastatic adenocarcinoma of the pancreas
• male or non-pregnant female
• years of age or greater
• one prior therapy for the treatment of metastatic disease
• must start continuation therapy within 9 months of starting first line treatment
• have adequate organ and bone marrow function
• must have a Karnofsky performance status greater than or equal to 70
• one or more metastatic tumors measurable by CT scan and accessible for biopsy

You may not qualify if:

• operable or locally advanced pancreatic cancer
• metastatic tumor that is not amendable to biopsy
• known brain mets unless previously treated and well controlled
• active, uncontrolled bacterial, viral or fungal infections
• known infection with HIV, hepatitis B or hepatitis C
• pregnant or breast-feeding patients

Sponsors & Collaborators

• Translational Drug Development: lead
• Scottsdale Healthcare: collaborator
• Stand Up To Cancer: collaborator
• American Association for Cancer Research: collaborator

Study Sites (1)

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Comparative Genomic Hybridization

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization

Study Officials

• Ramesh Ramanathan, MD

  TGen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

US (1)