Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
1 other identifier
interventional
106
1 country
1
Brief Summary
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Oct 2008
Typical duration for phase_2 pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFebruary 17, 2017
February 1, 2017
4.9 years
July 21, 2009
February 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to progression
Every 2 cycles until progression
Secondary Outcomes (5)
Safety profiles of gemcitabine/simvastatin
Every cycle until progression
Response rate
Every 2 cycles until progression
Duration of response
Every 2 cycles until progression
Overall survival
Every 3 months
Correlative analyses
after completion of accrual
Study Arms (2)
Gemcitabine+simvastatin
EXPERIMENTALGemcitabine and simvastatin
Gemcitabine+Placebo
PLACEBO COMPARATORGemcitabine plus Placebo
Interventions
Gemcitabine and simvastatin
Gemcitabine plus Placebo
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- ECOG performance status of 0\~2
- no radiotherapy within 1 month of the study entry
- measurable or evaluable lesion according to RECIST criteria
- no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
- adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
- written informed consent must be provided
You may not qualify if:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
- known history of hypersensitivity to study drugs
- patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Suk Park, M.D.,Ph.D.
Samsung Medical Center, Seoul, Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
October 1, 2008
Primary Completion
September 1, 2013
Study Completion
February 1, 2014
Last Updated
February 17, 2017
Record last verified: 2017-02