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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT01126892
Eligibility Criteria:
Inclusion Criteria:
Stratum 1:
1. Currently participating in Novartis study CAMN107A2109
2. Written signed and dated informed consent prior to any study procedures being performed
Stratum 2:
1. Male or female
2. \> 18 years
3. ECOG 0,1,2
4. ASL/ALT \<= 2.5 ULN or \<= 5.0 ULN
5. Alcaline Phosfatase \<= 2.5 ULN
6. Serum Bilirrubin \<= 1.5 ULN
7. Serum Creatinine \<= 1.5 ULN or creatinine clearance \>=50 ml/min / 24 hours
8. Serum Lipase \<= 1.5 ULN
Exclusion Criteria:
Stratum 1 and stratum 2:
1. Reduction of the cardiac function
2. Use of Coumadin
3. Other severe medical concurrent conditions
4. Treatment with medications that prolonged the QT interval.
5. Mayor surgery 15 days before the inclusion in the protocol
6. Pregnant women or lactation
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01126892
Study Brief:
Protocol Section:
NCT01126892