Status:
COMPLETED
A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer
Lead Sponsor:
Array BioPharma
Conditions:
Advanced Cancer
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of th...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Part 1):
- Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.
- No more than 3 prior anticancer regimens for advanced disease.
- Measurable or evaluable, nonmeasurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Able to take and retain oral medications.
- Additional criteria exist.
- Key Exclusion Criteria (Part 1):
- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
- Treatment with prior chemotherapy within 21 days of first dose of study drug.
- Requiring IV alimentation.
- Pregnancy or lactation.
- Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- History of being unable to tolerate gemcitabine or any of its components.
- Additional criteria exist.
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00862524
Start Date
March 1 2009
End Date
February 1 2011
Last Update
October 4 2012
Active Locations (6)
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1
Pinnacle Oncology/Hematology
Phoenix, Arizona, United States, 85258
2
Premiere Oncology
Santa Monica, California, United States, 90404-2111
3
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
4
Partners, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114