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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01813734
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed advanced NSCLC
* Molecular confirmation of a RET translocation
* At least one measurable lesion as defined by RECIST
* No restriction on number of prior therapies
* Estimated life expectancy of at least 12 weeks
* Able to swallow and retain orally administered medication
* Must agree to use an effective form of contraception from enrollment through 30 days after the end of study treatment
* Willingness and ability to comply with scheduled visits and study procedures
Exclusion Criteria:
* Clinically significant gastrointestinal abnormalities
* Pregnant or breastfeeding
* Major surgery within 28 days of initiating therapy
* History of CNS disease (Note: Participants with brain metastases will be eligible if treated appropriately and if they remain clinically stable).
* Anti-cancer therapy within 3 weeks
* History of significant bleeding disorder unrelated to cancer
* History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
* History of alcohol abuse
* Uncontrolled hypertriglyceridemia
* History of arterial thrombotic events (myocardial infarction, stroke or peripheral vascular disease).
* Uncontrolled hypertension
* Taking medications that are known to be associated with Torsades de Pointes
* Ongoing active infection
* Diagnosed with or received anti-cancer therapy for another primary malignancy within 3 years prior to entry (except for non-melanoma skin cancer or in situ cancers)
* Any condition or illness tha could compromise patient safety or interfere with the evaluation of the drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01813734
Study Brief:
Protocol Section:
NCT01813734