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A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity


Phase 1
35 Years
N/A
Not Enrolling
Both
Advanced Pancreatic Adenocarcinoma

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Trial Information

A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity


Inclusion Criteria:



- Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases

- Patient is scheduled to receive standard chemotherapy containing gemcitabine

- Patient has not received prior systemic therapy for advanced pancreatic
adenocarcinoma

- Patient must be available for periodic blood sampling, study-related assessments, and
management at the treating institution

Exclusion Criteria:

- Patient has had open abdominal surgery within 6 weeks of the screening visit

- Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the
screening visit

- Patient has an active infection, inflammation, or unresolved bowel obstruction

- Patient has poorly controlled diabetes

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Association of changes in FDG uptake with overall survival (OS)

Outcome Time Frame:

Week 3 and at least 7 months after the last patient is treated

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

2010_501

NCT ID:

NCT01050283

Start Date:

July 2010

Completion Date:

May 2012

Related Keywords:

  • Advanced Pancreatic Adenocarcinoma
  • Advanced pancreatic adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

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