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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT03892018
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent
* Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Measurable disease as per RECIST v1.1 criteria
* Adequate hematologic status
* Adequate liver function.
* Adequate renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months.
* Women must be postmenopausal or surgically sterile.
* Sexually active male subjects must use a barrier method of contraception during the study.
* Able to consume the prescribed meals
Exclusion Criteria:
* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
* Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
* Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
* Women of childbearing potential who are pregnant or breastfeeding.
* Currently taking a concomitant medication, other than a premedication, that is:
* A strong P-glycoprotein (P-gp) inhibitor or inducer.
* An oral medication with a narrow therapeutic index known to be a P-gp substrate.
* Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
* Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
* History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03892018
Study Brief:
Protocol Section:
NCT03892018