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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT00603356
Eligibility Criteria:
Inclusion Criteria:
* Histology or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists
* Age greater than or equal to 18 years
* ECOG PS 0-2
* ANC greater than or equal to 1.5 x 10\^9/L
* Bilirubin less than or equal to 1.5 x upper limit of normal (ULN), AST and ALT less than or equal to 2.5 x ULN
* Creatinine less than or equal to 1.5 ULN
* Predicted life expectancy greater than or equal to 12 weeks
* Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed
* Prior tyrosine kinase inhibitor therapy is permitted
* Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration
* Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months)
* Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects (a minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive)
* Prior surgery is permitted, provided that wound healing has occurred prior to registration
* Patients must use proactive effective contraceptive measures throughout the study
* Provide written informed consent
* Accessible for repeat dosing and follow-up
* Adequate hematopoietic, hepatic, and renal function
Exclusion Criteria:
* Significant cardiac disease unless well controlled
* Current or former smokers, unless patients stopped smoking greater than 3 months prior to registration
* Active or uncontrolled infections of serious illnesses or medical conditions that could interfere with participation
* History of unacceptable toxicity with previous EGFR inhibitor therapy
* History of any psychiatric condition that might impair the patient's ability to provide informed consent or participate
* Use of CYP3A4 inducers/inhibitors during the 14 days prior to first dose
* Pregnant or breast-feeding females
* Symptomatic brain metastases which are not stable, require steroids, are potentially life-threatening or that have required radiation within the last 28 days
* History of allergic reaction attributed to a similar compound as study drug
* GI abnormalities including inability to take oral medications, required for IV alimentation
* Clinically significant ophthalmologic abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00603356
Study Brief:
Protocol Section:
NCT00603356