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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT02673060
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed malignant tumor (breast cancer, prostate cancer etc)
* Bone metastases, documented by radiographs, bone scan
* No available standard chemotherapy or no indication for chemotherapy at the time of screening
* Eastern Cooperative Oncology Group \[ECOG\] status 0-2
* Adequate bone marrow function (hemoglobin ≥ 9 g/dL with or without transfusion requirement, absolute neutrophil count ≥ 1500/mm3, and platelets ≥ 75,000/mm3)
* Adequate liver function (bilirubin ≤ 2 x Upper Limit of Normal \[ULN\], Alanine aminotransferase \[ALT\] ≤ 2.5 x ULN).
* Adequate renal function (creatinine ≤ 1.5 x ULN) and creatinine clearance ≥ 50 mL/min \[measured or calculated by nomogram\]).
Exclusion Criteria:
* Systemic chemotherapy and/or investigational therapy within the previous 4 weeks
* Fracture ≤ 6 month prior the inclusion in the study
* Brain metastasis
* Serum calcium levels \< 8.5 mg/dL (\< 2.2 mmol/L)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02673060
Study Brief:
Protocol Section:
NCT02673060