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:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT01278758
Eligibility Criteria:
Inclusion Criteria:
* Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy;
* Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate;
* Creatinine clearance according to Cockcroft-Gault formula : Normal \> 80 mL/min, Mild 50-80 mL/min, Moderate 30-\<50 mL/min;
* A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies;
* Potassium, calcium, magnesium and phosphorus values within the normal range;
* Body Mass Index (BMI) must be within the range of 18 and 30
Exclusion Criteria:
* Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases;
* Patients with leptomeningeal disease metastases;
* Radiotherapy \</- weeks prior to starting study drug;
* Major surgery \</ 4 weeks prior to the start of study;
* Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug;
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01278758
Study Brief:
Protocol Section:
NCT01278758