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:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00040534
Eligibility Criteria:
Inclusion Criteria:
* Advanced cancer for which there is no treatment available which would have a reasonable chance of disease palliation or cure
* Age greater than or equal to 18.
* SWOG performance Status less than or equal to 2.
* Meets protocol requirements for specified laboratory values.
* Written informed consent and cooperation of patient.
Exclusion Criteria:
* Prior treatment with an FPTI
* Knowledge of intracranial metastases or carcinomatous meningitis.
* Poor medical risks because of nonmalignant systemic disease or uncontrolled active infection.
* Medical conditions that would interfere with taking oral medications.
* Significant uncontrolled diarrhea.
* Chemotherapy, radiotherapy or major surgery within 4 weeks; full recovery from prior treatment.
* Concomitant use of CYP3A inhibitors/inducers per protocol.
* Known HIV positivity or AIDS-related illness.
* Pregnant or nursing women.
* Men or women of childbearing potential who are not using an effective method of contraception.
* Concurrent chemotherapy, hormonal therapy, radiotherapy or immunotherapy.
* QTc prolongation (\>440 msecs) at baseline.
* Patients with previous high-dose therapy requiring stem cell rescue or bone marrow transplant, or irradiation to \>30% of bone marrow-containing areas.
* Patients that have received Mitomycin-C or nitrosoureas.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00040534
Study Brief:
Protocol Section:
NCT00040534