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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT00195156
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologic confirmation of a solid tumor malignancy with clinical evidence of metastatic disease.
* Patients must have failed at least one standard therapy, if available, for their malignancy. Patients may be entered on the trial without prior therapy if there is no standard effective therapy available.
* No active brain metastases or epidural tumor.
Exclusion Criteria:
* Concomitant administration of steroids.
* Irradiation or chemotherapy within 14 days of start of protocol.
* Evidence of another active cancer, except for non-melanoma, carcinoma of the skin and in-situ carcinoma of the cervix curatively treated, Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for greater than 5 years.
* Women who are pregnant or lactating. Women or men of reproductive age who are unwilling to use two forms of effective contraception.
* Patients with clinically significant cardiac, renal or hepatic disease; severe debilitating pulmonary disease; or history of diabetes mellitus prone to ketoacidosis.
* Patients with a history of pancreatitis.
* Patients with known hypersensitivity to retinoids or retinoic acid derivatives.
* Patients with coagulation disorders, such as thrombophlebitis or pulmonary embolism.
* Patients with pre-existing psychiatric condition, especially depression or a history of severe uncontrolled psychiatric disorder.
* Patients with pre-existing thyroid abnormalities whose thyroid function cannot be maintained in the normal range.
* Patients with chronic moderate to severe nausea.
* Patients with history of epilepsy or a seizure disorder taking anti-convulsant medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00195156
Study Brief:
Protocol Section:
NCT00195156