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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT00689195
Eligibility Criteria:
Inclusion Criteria:
* Patients (between the ages of 8 to 65 years) with histologically proven high grade osteosarcoma of the extremity and relapsed disease after primary line of treatment who are unsuitable or refuse secondary chemotherapy.
* Patients with advanced disease unable or unwilling to take primary conventional treatment
* Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.
* Adequate hepatic function defined by total bilirubin not more than 1.5 times the upper limit of normal (ULN) and SGOT and SGPT not more than 2.5 times the (ULN)
* Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by cockcroft-Gault formula
Exclusion Criteria:
* Patients who are suitable for second line chemotherapy and can afford it
* Age less than 8 years or greater than 65 years
* Pregnant or lactating women
* Patients who are unable or unwilling to provide blood samples for the drug assays.
* Low grade osteosarcoma
* Patient requiring treatment with CYP3A4 inducers or inhibitors (patients on treatment for epilepsy or tuberculosis)
* Participation in any investigational drug study within 28 days prior to study treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
65 Years
Study:
NCT00689195
Study Brief:
Protocol Section:
NCT00689195