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 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT01454804
Eligibility Criteria:
Inclusion Criteria:
1. Patients with advanced cancer should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that improves survival by at least three months.
2. Patients must have measurable or evaluable disease.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
4. Abnormal organ function is permitted; however, patients must have : Plt \>/=100,000/, absolute neutrophil count (ANC) \>/=1500, total Bilirubin \</=2.0 mg/dl, Creatinine \</=2.0 mg/dl and Prothrombin Time/International Normalized Ratio/Partial Thromboplastin Time (PT/INR/PTT) within 1.5 X upper limit of normal (ULN).
5. A woman is eligible to enter and participate in the study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had a hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation, is post-menopausal (total cessation of menses for ≥ 1 year); OR if of childbearing potential, has a negative serum pregnancy test at screening, and agrees to use adequate contraception.
6. A man with a female partner of childbearing potential is eligible to enter and participate in the study if he uses a barrier method of contraception or abstinence during the study.
7. Signed informed consent approved by the Institutional Review Board prior to patient entry.
8. Expanded Cohort only: Patients must have HER2 amplification, HER2 mutation, c-Met amplification, c-Met mutation, EML4-ALK translocation, or epidermal growth factor receptor (EGFR) mutation.
Exclusion Criteria:
1. Poorly-controlled hypertension (systolic blood pressure \[SBP\] \>/= 140 mmHg, or diastolic blood pressure \[DBP\]\>/= 90 mmHg).
2. Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes,congestive cardiac failure )
3. History of myocardial infarction, admission for unstable angina, cardiac angioplasty or stenting within three months of Day 1 of treatment period.
4. History of venous or arterial thrombosis within 3 months of Day 1 of treatment Period.
5. Current use of therapeutic warfarin. NOTE: both low molecular weight heparin and prophylactic low-dose warfarin are permitted; however, PT/PTT must meet above inclusion criteria.
6. Excessive risk of bleeding or thrombosis as defined by stroke or severe bleeding within the prior 6 months.
7. Patients who received investigational drugs, chemotherapy or immunotherapy patient must be \>/= five half-lives or \>/= 3 weeks from the last dose of treatment, whichever is shorter.
8. Any major surgery or radiotherapy within 14 days of treatment.
9. Patients with a documented Left Ventricular Ejection Fraction \< 45%.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01454804
Study Brief:
Protocol Section:
NCT01454804