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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT01296659
Eligibility Criteria:
Inclusion Criteria:
* Advanced or metastatic soft tissue sarcoma with histological or cytological proven disease. No more than 2 lines of chemotherapy in the metastatic setting in the dose escalation phase, and no more than one line of prior therapy in the expansion phase.
* ECOG performance status of ≤ 1
* A minimum life expectancy \> 3 months
* At least 4 weeks must have elapsed between prior investigational therapy, chemotherapy or radiotherapy and the first dose of ridaforolimus
* Adequate hematological, hepatic and renal function (hemoglobin ≥ 9g/dl, absolute neutrophil count \[ANC\] ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; bilirubin ≤ ULN; alkaline phosphatase ≤ 2.5 x ULN; AST, ALT ≤ 2.5 x ULN; albumin ≥ 2.5mg/dL; creatinine ≤ 1.5 x ULN)
* Serum cholesterol ≤ 350 mg/dL and triglycerides ≤400 mg/dL
* Signed informed consent
* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to start of therapy and must use an approved contraceptive method as appropriate from the time of screening until 30 days after the last dose of study drug.
Exclusion Criteria:
* Uncontrolled brain metastases, spinal cord compression, or carcinomatous meningitis.
* Clinically significant unexplained bleeding within 28 days prior to entering the trial
* Uncontrolled systemic vascular hypertension
* Clinically significant cardiovascular disease
* Newly diagnosed (within 3 months of enrollment) or poorly controlled type 1 or 2 diabetes
* Have received \>350 mg/m2 total dose of Doxorubicin
* Active infection requiring prescribed intervention
* Other concurrent illness
* Major surgery within 28 days before trial entry, or incompletely healed surgical incision; minor surgery or procedures within 7 days
* Previous anthracycline lifetime exposure more than 350 mg/m2 would exclude patient form AIM Arm enrollment
* Pregnant or breastfeeding
* Known allergy to macrolide antibiotics
* Concurrent treatment with medications that induce or inhibit cytochrome P450 (CYP3A).
* Known history of HIV sero-positivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01296659
Study Brief:
Protocol Section:
NCT01296659