The I-phase clinical trial of high-capacity Simvastatin in patients with gastrointestinal cancer that failed standard chemotherapy
- Conditions
- Neoplasms
- Registration Number
- KCT0003294
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
1.Test subjects with the intent and ability to provide written consent/approval for this clinical trial.
2. Test subjects with an age of 20 or older at the time of signing the consent of the test subjects (or the higher of acceptable age according to local regulations).
3. Organically or cytologically tested for colorectal or gastric cancer
4. In case of colon cancer, treatment (cetRuxMab) was performed only after 5FU or capecetamine, irinotcan, octifatin, bvacizumab and cetuximab
5. In case of stomach cancer, subjects tested after secondary chemotherapy.
6.Test subjects with a status of 0 or 1 on the ECOG performance scale.
7. Test subjects who determined that there was a disease that could be assessed based on RECIST v1.1
8.PK test subjects willing to provide blood samples for analysis.
9. Test subjects to swallow and maintain oral medication.
10. Test subjects tested for proper long-term capability. All screening clinical laboratory examinations are conducted within 14 days prior to commencement of treatment.
Table 1 Clinical laboratory values for appropriate long-term functions
Clinical laboratory figures
(hematology)
Absolute neutrophil count =1,500 /mCL
Platelets =100,000 / mCL
Hemoglobin =9 g/dL
(Mouth)
serum creatine or
Measured or calculateda creatine cleaning rate
(GFR (Glomerular Filtering Rate) =1.5 X Normal (ULN:upper limits)
instead of creatine or CrCl
60mL/min for test subjects with creatine level > 1.5X testing agency ULN
(Liver)
Total serum bilirubin = 1.5 ULN
AST (SGOT) and ALT (SGPT) = 3 X ULN
(blood clotting)
International Normalization Ratio (INR) or Protrombin Time (PT)
Enabled Partial Tromboplastin Time (aPTT) If the test subjects are not receiving anticoagulance therapy and the PT or PTT is within the therapeutic range of the intended anticoagulant use =
= ULN if the test subjects are not receiving anticoagulance therapy and PTT or PTT is within the therapeutic range of the intended anticoagulant use.
aCretin cleaning rate shall be calculated in accordance with the testing agency standard.
11. Female test subjects should have a urine or serum pregnancy test voice within 72 hours prior to administration of the initial dose of the test drug. If the urine test is positive or negative, a serum pregnancy test is required.
12. Female test subjects are willing to use two methods of contraception, surgical infertility, or heterosexual sex during the clinical trial until 120 days after the final dose of the drug. The test subjects are women who are not clinically infertile or have no menstrual periods for one year.
13. Male test subjects should agree to use appropriate contraception starting with the initial administration of clinical trial treatments until 120 days after final administration of clinical trial treatments.
1. Past history of use of statins within 12 months of clinical trial participation
2. Test subjects with severe revenge or metastatic fracture
3.Active central nervous system (CNS) transfer and/or cancer meningitis are known to be tested. Test subjects with previously treated brain transitions are stable (if they are not used for at least four weeks prior to the initial administration of clinical trial treatments, there is no evidence of at least seven weeks of progress by video, and no evidence of new or extended brain transfer). This exception does not include cancerous meningitis, which excludes clinical stability.
4. Additional malignant tumors that are currently in progress or require active treatment are tested. Exceptions include skin basal cell carcinoma or skin flat cell cancer or cervical cervical cervical endodermal cancer, which has been treated with potential full-treatment.
5. Test subjects with active infection requiring telemedicine.
6. Disrupting or participating in clinical trial results as determined by the treatment tester or disrupting participation of test subjects during the entire clinical trial period has a history or current evidence of any condition, therapy or clinical laboratory abnormalities for the test subjects.
7. Persons who are tested for mental or substance abuse that may interfere with cooperation in clinical testing requirements.
8. A person who is pregnant or breastfeeding, or who plans to become pregnant or father of a child within the expected clinical trial period of 120 days after the final dose of a clinical trial treatment, starting with a pre-scanning or screening visit.
9. Test subjects whose past history of the human immunodeficiency virus (HIV) (HIV 1/2 antibody) is known.
10. Test target with CPK > ULN in the baseline.
11. Powerful CYP3A4 inhibitors, such as Clarithromycin, erythromzzanine, itraconazole, nefazone, etc.
12. A person with a history of muscular dystrophy/translipidosis (including patients with rhabdomyolysis or muscular dystrophy with statin or fibrate medication)
13. Patients whose CK level has increased more than five times their normal limit during previous treatment of statins
14. Unregulated hypothyroidism
15.Galactose intolerance, lapp lactase deficiency, or glucose-alactose absorption
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method simvastatin (MTD:Maximum Tolerable Dose), (DLT:Dose limiting toxicity)
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of plasma thimbastatin and thimbastatinic acid