A Phase I Study of High Dose Simvastatin in Patients With Gastrointestinal Tract Cancer Who Failed to Standard Chemotherapy
NCT ID: NCT03086291
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
9 participants
INTERVENTIONAL
2018-01-04
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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simvastatin
One arm Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days Cohort 1: 7.5 mg/kg bid for 7 days 14 days off Cohort 2: 10 mg/kg bid for 7 days 14 days off Cohort 3: ( ) mg/kg bid for 7 days 14 days off (to be determined based on PK data of cohort 1 and 2) Q 3 weeks
Simvastatin
Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days
Interventions
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Simvastatin
Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days
Eligibility Criteria
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Inclusion Criteria
2. Be 20 years of age on day of signing informed consent
3. Have histologically or cytologically confirmed diagnosis of colorectal cancer or gastric cancer
4. For colorectal cancer, patients who progressed after 5FU or capecitabine, irinotecan,oxaliplatin, bevacizumab and cetuximab treatment (cetuximab is only for KRAS/NRAS wild type)
5. For gastric cancer, patients who progressed after second line chemotherapy.
6. Have a performance status of 0 or 1 on the ECOG Performance Scale.
7. Have evaluable disease based on RECIST v1.1 as determined by investigator.
8. Be willing to provide blood sample for PK analysis.
9. Ability to swallow and retain oral medication.
10. Demonstrate adequate organ function
Exclusion Criteria
2. Patients with massive ascites or disseminated bone metastases
3. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
5. Has an active infection requiring systemic therapy.
6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
7. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
8. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
9. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
10. Patients with CPK \> ULN at baseline
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Won Ki Kang
professor
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Won Ki Kang, MD
Role: primary
Other Identifiers
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2017-02-138
Identifier Type: -
Identifier Source: org_study_id