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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT01152203
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically confirmed cancer.
2. Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months.
3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (\>10) or Lansky (\<10).
4. Adequate renal function (serum creatinine \</= 2.0 mg/dL or the calculated Glomerular Filtration Rate (GFR) \>/= 40 mL/min if creatinine \> 2.0 mg/dL). Pediatric: serum creatinine \</= 1.5 mg/dL or 2x upper limit of normal, for age.
5. Hepatic function: total bilirubin \</= 1.0 mg/dL (Patients with Gilbert's Syndrome must have a total bilirubin \</= 3.0 mg/dL); ALT \</= 3 times upper limit of normal. If patient has liver metastases, total bilirubin \</= 5 mg/dL; ALT \</= 5 times upper limit of normal.
6. Adequate bone marrow function (Absolute neutrophil count (ANC) \>/= 1,000 cells/uL; Platelets (PLT) \>/= 75,000 cells/uL), unless these abnormalities are due to bone marrow involvement.
7. At least three weeks from previous cytotoxic chemotherapy. After targeted or biologic therapy there should be 5 half-lives or 3 weeks, whichever is shorter.
8. All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). Patients should not become pregnant or breast-feed while on this study. Sexually active patients should use effective birth control.
9. Must be \>/= 13 years of age.
10. Sign informed consent. Pediatric participants: age 13-17 would sign assent, parent or guardian would sign consent.
Exclusion Criteria:
1. Pregnant females.
2. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
3. Serious or non-healing wound, ulcer or bone fracture.
4. Uncontrolled systemic vascular hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg).
5. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection requiring parental antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
6. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
7. Patients with clinical bleeding, active gastric or duodenal ulcer.
8. Patients with history of bleeding central nervous system (CNS) metastasis will be excluded from the trial.
9. Patients with major surgery within 28 days prior to entering the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT01152203
Study Brief:
Protocol Section:
NCT01152203