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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01676818
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of invasive cervical cancer
* Measurable disease
* 0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy
* Absolute granulocyte count (AGC) \>= 1,500
* Platelet \>= 100,000
* Serum creatinine \< 2.0 mg/dl
* Bilirubin =\< 1.5 times the upper limit of the normal range (ULN)
* Alkaline phosphatase =\< 3 x ULN (in the case of liver metastases, =\< 5 x ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (in the case of liver metastases, =\< 5 x ULN)
* Peripheral neuropathy grade 0-2
* Recovery of all chemotherapy or radiation-related toxicities to grade =\< 1, except for alopecia and peripheral neuropathy
* Performance status 0-2
* Signed informed consent
Exclusion Criteria:
* Prior treatment with eribulin
* Chemotherapy, radiation, or biological or targeted therapy within 3 weeks
* Hormonal therapy within 1 week
* Any investigational drug within 4 weeks
* Known brain metastases, unless previously treated and asymptomatic for 3 months and not progressive in size or number for 3 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01676818
Study Brief:
Protocol Section:
NCT01676818