NCT00055250CompletedPhase 2
A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of Gemcitabine Plus LY293111 Compared to Gemcitabine Plus Placebo in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- 6-month survival
Study Overview
Brief Summary
The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients with pancreatic cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent
- •Tumor that can be measured by x-ray or scan
- •Adequate organ function
Exclusion Criteria
- •Inability to swallow capsules
- •Documented brain metastases
- •Prior chemotherapy or biological therapy for this disease
Outcomes
Primary Outcomes
6-month survival
Secondary Outcomes
- Toxicity
- tumor response
- PK
Investigators
Study Sites (1)
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