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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT01663857
Eligibility Criteria:
Inclusion Criteria:
* Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
* Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment
* Are able to swallow tablets
* Have given written informed consent prior to any study procedures
* Have adequate blood counts, hepatic and renal function
* Have performance status equal to or less than 2 on Eastern Cooperative Oncology Group (ECOG) scale
* Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug
Exclusion Criteria:
* Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
* Are currently enrolled or discontinued less than 14 days from another clinical trial
* Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.
* Must not be pregnant or breastfeeding.
* Have malignancy or metastasis of the central nervous system
* Have borderline malignancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01663857
Study Brief:
Protocol Section:
NCT01663857