A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Neoplasm
Both
Pancreatic Neoplasm
Trial Information
A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Inclusion Criteria:
- Diagnosis of adenocarcinoma of the pancreas.
- Pretreatment tumor specimen must be available.
- No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for
pancreatic cancer, including 5FU with radiation therapy.
- Prior radiation allowed.
- Ability to stop some types of anti-seizure medicines within 14 days of enrollment.
Exclusion Criteria:
- Endocrine pancreatic tumor or ampullary cancer.
- Central Nervous System metastases.
- Inability to swallow tablets.
- 10% or greater weight loss over the 6 weeks before study entry.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
baseline to the date of death from any cause.
Safety Issue:
Yes
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
10463
NCT ID:
NCT00267020
Start Date:
December 2005
Completion Date:
May 2008
Related Keywords:
- Pancreatic Neoplasm
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| For additional information regarding invesigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician | Dallas, Texas |
