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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01214668
Eligibility Criteria:
Inclusion Criteria:
* You must have a histologically confirmed solid malignancy that is unresectable and/or metastatic which has progressed after receiving standard approved chemotherapy
* You must have a solid malignancy for which an anthracycline-based regimen is felt to be a reasonable treatment option
* You must have measurable disease or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
* You must have a serum albumin level greater than or equal to 3.0 grams/deciliter (g/dL) (30 g/L)
* You must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* You must have tumor progression after receiving standard/approved chemotherapy
* You must be reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures
* Women must be sterile, post-menopausal or on a contraception and men must be sterile or on contraception
* Your test results assessing the function of your blood, kidneys, liver, and heart are satisfactory
* Ovarian patients in the confirmation phase must have failed to achieve at least a partial response to a first-line platinum-based therapy (platinum-refractory) or have progression in less than 6 months after a response to a first-line platinum-based therapy (platinum-resistant)
* Ovarian patients in the confirmation phase must have measurable disease by RECIST
* Ovarian patients in the confirmation phase must be liposomal doxorubicin or doxorubicin naive and not amendable to curative therapy
Exclusion Criteria:
* You cannot have received other investigational drugs within the last 28 days
* You cannot have other on-going serious illnesses including active bacterial, fugal, or viral infections
* You cannot have current hematologic malignancies, acute or chronic leukemia, or brain metastasis
* You cannot currently be receiving warfarin (Coumadin®) therapy
* You cannot have known positive test results in human immunodeficiency, hepatitis B surface antigen or hepatitis C antibodies
* You cannot have a history of cardiac disease or clinical evidence of congestive heart failure
* Ovarian patients in the confirmation phase who have received 2 or more cytotoxic regimens for platinum-resistant disease
* You cannot currently be receiving amiodarone, quinidine, propofol, and clozapine
* If you are taking esomeprazole or pantoprazole you must be able to stop taking this medication within 72 hours before and after LY573636 administration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01214668
Study Brief:
Protocol Section:
NCT01214668