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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT01611961
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 and \< 65, with ECOG performance status 0-1,and Life expectancy of more than 3 months.
2. Have advanced (local and/or metastatic) histologically documented cancer considered unresponsive to available conventional modalities or treatments.
3. Have recovered from acute toxicities of prior treatment:
* 4 weeks must have elapsed since receiving any investigational agent.
* 4 weeks must have elapsed since receiving any radiotherapy, or treatment with cytotoxic or biologic agents (≥6 weeks for mitomycin or nitrosoureas).
* 4 weeks must have elapsed since any prior surgery.
4. Be in adequate condition as evidenced by the following clinical laboratory values:
* Absolute neutrophil count (ANC) ≥1,500/mm3.
* Platelets ≥ 80,000/mm3.
* Hemoglobin ≥ 9.0 g/dL.
* WBC ≥ 4,000/mm3.
* Total bilirubin ≤ 2.5 x institutional upper limit normal (ULN).
* Transaminases AST (SGOT) and ALT (SGPT) ≤ 1.5 times ULN or ≤ 5 times ULN (liver metastasis).
* Serum creatinine ≤ 1.2 times ULN, blood urea nitrogen≤ 1.2 times ULN.
5. both female and male patients must use adequate methods of contraception.
6. Patient or legal representative must understand the investigational nature of this study and sign an Institutional Review Board (IRB)/Independent Ethics Committee approved written informed consent form prior to treatment.
Exclusion Criteria:
1. Intolerance to any antineoplastic agents belonging to the taxoid family.
2. having failed a docetaxel-containing regimen or Having known non-controllable hypersensitivity to docetaxel or lipid microsphere.
3. Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
4. Unstable or uncontrolled cardiac disease or hypertension.
5. With other serious internal diseases, uncontrolled infection or uncontrolled diabetes.
6. With Symptomatic brain metastasis not controlled.
7. Having pre-existing clinically significant neuropathy (NCI CTCAE Grade ≥ 2 neuromotor or Grade ≥ 2 neurosensory) except for abnormalities due to cancer.
8. Currently receiving any other standard or investigational treatment for cancer or any other investigational agent for any indication.
9. Requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
10. Female patients who are pregnant or breast-feeding.
11. Unwilling or unable to follow protocol requirements.
12. With history of serious allergic or allergy.
13. Not fit for the clinical trial judged by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01611961
Study Brief:
Protocol Section:
NCT01611961