Pancreatic CancerPhase 2NCT00944463
Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
A Phase 2 study testing Gemcitabine+simvastatin in people with Pancreatic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Gemcitabine+simvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
Read the detailed description
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine+simvastatin, Gemcitabine+Placebo
- Keywords
- advanced pancreatic cancer, gemcitabine, simvastatin, placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine+simvastatinDrug
Also called Gemcitabine and simvastatin
Gemcitabine and simvastatin
Gemcitabine+PlaceboDrug
Also called Gemcitabine plus Placebo
Gemcitabine plus Placebo
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine+simvastatin | Experimental | Gemcitabine and simvastatin Receives: Drug: Gemcitabine+simvastatin |
| Gemcitabine+Placebo | Placebo comparator | Gemcitabine plus Placebo Receives: Drug: Gemcitabine+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: Every 2 cycles until progression
Secondary outcomes (5)
Safety profiles of gemcitabine/simvastatin
Measured: Every cycle until progression
Response rate
Measured: Every 2 cycles until progression
Duration of response
Measured: Every 2 cycles until progression
Overall survival
Measured: Every 3 months
Correlative analyses
Measured: after completion of accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Suk Park, Samsung Medical Center
- Investigators
- Young Suk Park, M.D.,Ph.D., Principal investigator, Samsung Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944463
- Sponsor's protocol ID
- 2008-07-065
- Status last verified
- Feb 2017
- First submitted
- 21 Jul 2009
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT00944463
- Acronym / sponsor ID
- 2008-07-065
- Conditions
- Pancreatic Cancer
- Keywords
- advanced pancreatic cancer, gemcitabine, simvastatin, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
Detailed description
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine+simvastatin | Experimental | Drug: Gemcitabine+simvastatinGemcitabine and simvastatin |
| Gemcitabine+Placebo | Placebo comparator | Drug: Gemcitabine+PlaceboGemcitabine plus Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
- ECOG performance status of 0~2
- no radiotherapy within 1 month of the study entry
- measurable or evaluable lesion according to RECIST criteria
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine+simvastatinAlso: Gemcitabine and simvastatinGemcitabine and simvastatin | Drug | Gemcitabine+simvastatin |
| Gemcitabine+PlaceboAlso: Gemcitabine plus PlaceboGemcitabine plus Placebo | Drug | Gemcitabine+Placebo |
Primary outcome
Time to progression
Time frame: Every 2 cycles until progression
5 secondary outcomes
Safety profiles of gemcitabine/simvastatin
Time frame: Every cycle until progression
Response rate
Time frame: Every 2 cycles until progression
Duration of response
Time frame: Every 2 cycles until progression
Overall survival
Time frame: Every 3 months
Correlative analyses
Time frame: after completion of accrual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Suk Park, M.D.,Ph.D. principal investigator
Samsung Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine+simvastatin in people with Pancreatic Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: Every 2 cycles until progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.