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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01737502
Eligibility Criteria:
Inclusion Criteria:
* Histologic or cytologic confirmation of lung cancer (squamous, ras-mutated adenocarcinoma or small cell lung cancer)
* Patients must have received at least one course of chemotherapy consisting of a platinum doublet and must have no acceptable standard treatment options
* Prior radiation therapy is permitted as long as:
* Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
* Absolute neutrophil count (ANC) \>= 1500 uL
* Platelets (PLT) \>= 100,000 uL
* Hemoglobin (Hgb) \>= 9 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN is acceptable if liver has tumor involvement
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
* Negative serum pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Ability to provide informed consent
* Life expectancy \>= 12 weeks
* Willing to return to Mayo Clinic enrolling institution for follow-up
* Willing to provide tissue samples for correlative research purposes
Exclusion Criteria:
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases or seizure disorder; NOTE: patients with treated CNS metastases without evidence of progression and without uncontrolled symptoms or need for steroids may enroll
* Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded
* Unwilling or unable to, comply with the protocol
* Any of the following prior therapies:
* Radiation to \>= 25% of bone marrow
* Major surgery (i.e., laparotomy), open biopsy, or significant traumatic injury =\< 4 weeks prior to registration; minor surgery =\< 2 weeks prior to registration; insertion of a vascular access device is not considered major or minor surgery in this regard
* Any of the following concurrent severe and/or uncontrolled medical conditions:
* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication
* Angina pectoris
* History of congestive heart failure =\< 3 months, unless ejection fraction \> 40%
* Myocardial infarction =\< 6 months prior to registration
* Cardiac arrhythmia
* Poorly controlled diabetes
* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for \> 14 days, patients may be considered for participation in this study
* \>= Grade 2 hypertriglyceridemia
* \>= Grade 2 hypercholesterolemia
* Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial
* Use of St. John's Wort because of its effects on hepatic drug metabolism
* Other active malignancy: EXCEPTIONS: Non-melanoma skin cancer, localized prostate cancer, or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, patient must not be receiving other cytotoxic or molecularly targeted therapeutics treatment for their cancer; patients receiving certain hormonal manipulations as part of their treatment may be allowed to continue at the discretion of the Principal Investigator (PI) (e.g. luteinizing hormone-releasing hormone \[LHRH\] analogs for prostate cancer)
* Unable to discontinue use of potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors/inducers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01737502
Study Brief:
Protocol Section:
NCT01737502