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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT01041235
Eligibility Criteria:
Inclusion Criteria:
* Understand and sign a written IRB-approved informed consent form.
* Have a histologically confirmed solid tumor.
* Have progressive disease following standard/approved chemotherapy or have no appropriate alternative therapy available.
* Have one or more tumors measurable or evaluable as outlined by modified RECIST or evaluable by CT or MRI scan.
* Have an ECOG performance status of ≤ 2.
* Have a life expectancy of at least 3 months.
* Be ≥ 18 years old.
* Have a negative pregnancy test (if female of childbearing potential)
* Demonstrate acceptable hepatic function:
* Bilirubin ≤ upper limit of normal (ULN)
* AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN
* Demonstrate acceptable renal function:
* Serum creatinine ≤ 1.5 x ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Calculated according to the Cockroft and Gault formula)
* Demonstrate acceptable hematologic status:
* Absolute neutrophil count ≥ 1500/mm3
* Platelet count ≥ 100,000/mm3 (measured within 72 hours prior to initial dose)
* Hemoglobin ≥ 9 g/dL
* Demonstrate acceptable coagulation status:
* PT or INR within 1.5x ULN
* PTT within 1.5x ULN
* Have recovered from prior treatments (eg, surgery, radiation, chemotherapy, investigational therapies) sufficiently prior to Day 1 so that, in the opinion of the Investigator and/or Medical Monitor, the protocol objectives would not be compromised.
* Agree to use an effective contraceptive method (hormonal or barrier method; or abstinence) for the duration of the study and for 30 days after the last dose (for men and women of child-producing potential).
Exclusion Criteria:
* Have New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG).
* Have a seizure disorder requiring anticonvulsant therapy.
* Have active CNS metastasis. Patients with a history of CNS metastases will be eligible if they have been treated and are stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on stable dose of steroids for ≥ 1 week prior to enrollment.
* Have severe, chronic obstructive pulmonary disease with hypoxemia.
* Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
* Are pregnant or nursing.
* Have undergone radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
* Are unwilling or unable to comply with procedures required in this protocol.
* Have a known history of infection with HIV, hepatitis B, or hepatitis C.
* Have a serious nonmalignant disease that, in the opinion of the Investigator and/or the Medical Monitor, could compromise protocol objectives.
* Are currently receiving any other investigational agent.
* Have exhibited allergic reactions to docetaxel, or a similar structural compound, biological agent, or formulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01041235
Study Brief:
Protocol Section:
NCT01041235