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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT01141257
Eligibility Criteria:
Inclusion Criteria:
* Males or females with advanced, recurrent or metastatic cancer, refractory to standard therapy;
* Age ≥18 years;
* Signed informed consent form and ability to understand the study procedures.
Exclusion Criteria:
* Concomitant anticancer therapy, including radiation;
* Current or previous (within 30 days of first study dosing) treatment with another investigational drug or participation in another clinical study;
* Chronic daily treatment with aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day);
* Chronic daily treatment with corticosteroids, with the exception of inhaled steroids;
* Inadequate bone marrow function;
* Inadequate liver function;
* Inadequate renal function;
* Patients not receiving anticoagulant medication who have an International Normalized Ratio (INR) \>1.5 or an activated partial thromboplastin time (aPTT) \>1.5 x ULN within 7 days prior to first study treatment;
* Patients with lymphomas;
* Evidence of spinal cord compression or brain metastases;
* Other malignancy diagnosed within the previous 5 years;
* Pregnant or lactating females.;
* All patients who do not use a highly effective method of birth control;
* Major surgical procedure (including open biopsy) within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment;
* Minor surgical procedures, within 24 hours prior to the first study treatment;
* History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding;
* Uncontrolled hypertension or clinically significant (i.e. active) cardiovascular disease;
* History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra-abdominal abscess within 6 months of enrollment;
* Lung carcinoma of squamous cell histology or any histology in close proximity to a major vessel;
* Serious non-healing wound, peptic ulcer or bone fracture;
* Known hypersensitivity to the study medication or any of its excipients;
* Evidence of any other medical conditions that may interfere with the planned treatment, affect patient compliance or place the patient at high risk of treatment-related complications;
* Previous enrollment in this study;
* Known hepatitis B or C or HIV infection;
* Employees of the sponsor or patients who are employees or relatives of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01141257
Study Brief:
Protocol Section:
NCT01141257