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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
This is a Phase 1, open-label, single center, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of high dose simvastatin in patients with GI cancers. Three dose levels will be evaluated. Simvastatin will be given at escalating dose of 7.5mg/kg bid, 10mg/kg bid and ( ) mg/kg bid for 7 days and off treatment for 14 days (Final dose will be determined based on PK data of cohort 1 and 2). The treatment will be repeated every 3 weeks. The cohort size of at least 3 and up to 6 patients ('rolling six design') will be employed to improve the rate of accrual of patients to cohorts close to the presumed therapeutic dose by reducing the need for late replacement of patients who become non-evaluable during the DLT assessment period, whilst not compromising collection of safety data. The total number of patients will depend upon the number of dose adjustments necessary. And intra-patient dose escalation is not allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose | maximum tolerated dose | 12months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wonki kang, ph.D | Contact | 82-2-3410-3459 | wonki.kang@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-720 | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |