Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-24 @ 12:14 PM
NCT ID:
NCT01281761
Eligibility Criteria:
Inclusion Criteria:
1. Histologically-confirmed, advanced/metastatic colorectal carcinoma Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (last regimen has to be irinotecan-based chemotherapy; To be eligible, patients must also have received one of several qualifying, irinotecan regimens for at least 6 weeks and must have had documented progression of disease during receipt of this regimen or within six months thereafter.
2. Ras mutation (+) (checked at the central lab)
3. At least one measurable tumor mass according to RECIST 1.1
4. Expected survival for approximately 12 weeks or longer
5. Karnofsky Performance Score (KPS) ≥ 70
6. Age ≥ 18 years
7. WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
8. ANC ≥ 1,500 cells/mm3
9. Hemoglobin ≥ 10 g/dL (transfusion allowed)
10. Platelet count ≥ 100,000 plts/mm3
11. Total bilirubin ≤ 1.5ULN
12. AST, ALT ≤ 2.5 ULN (if liver metastases(+): AST,ALT ≤5.0 x ULN)
13. Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic or have a screening random glucose \> 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
14. Written informed consent
Exclusion Criteria:
1. Prior simvastatin therapy within 1-year from the date of study entry
2. Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal mediation and/or coronary angioplasty (including stent placement) within the preceding 24 months
3. Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
4. Patients with CPK \> 5 x ULN at baseline
5. Patients with alcohol abuse
6. Uncontrolled hypothyroidism
7. Concomitant use with clarithromycin, erythromycin, itraconazole, ketoconazole, nefazodone, telithromycin
8. Concomitant use of gemfibrozil, cyclosporine, danazol, amiodarone, verapamil
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01281761
Study Brief:
Protocol Section:
NCT01281761