Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically proven diagnosis of advanced lung adenocarcinoma
KRAS mutation
You may not be if
Able to take oral medications
Measurable disease as per RECIST 1.1. Previously irradiated sites of tumor may be considered measurable if there is radiographic progression at the site subsequent to the time of completing radiation.
Karnofsky performance status (KPS) ≥ 70%
Age \>18 years old
Adequate organ function:
* AST, ALT ≤ 2.5 x ULN - Total bilirubin ≤ 1.5 x ULN -Albumin ≥ 2.5g/dL
* Creatinine \< 1.5 x ULN OR calculated creatinine clearance ≥ 50mL/min
* Amylase and lipase within normal limits (amylase ≤ 100, lipase ≤ 78)
Female patients who:
* Are postmenopausal for at least 1 year before the screening visit, OR
* Are surgically sterile, OR
* If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
* Agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study drug, or
* Agree to completely abstain from heterosexual intercourse
Patients with symptomatic brain metastasis requiring escalating doses of steroids
Patients with grade 2 or greater diarrhea prior to study initiation despite maximal medical management
History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
History of or ongoing alcohol abuse that, in the opinion of the Investigator, would compromise compliance or impart excess risks associated with study participation.
Pregnant or lactating women
Any type of systemic therapy (chemotherapy or experimental drugs) within 2 weeks of starting treatment on protocol
Patients who have received prior treatment with MEK inhibitor
A history of clinically significant interstitial lung disease or pneumonitis
Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to: History of clinically significant (as determined by the treating physician) atrial arrhythmia; or any ventricular arrhythmia, History of congenital long QT syndrome., Abnormal QTc (≥ 450 msec in males and ≥ 470 msec in females), Ejection fraction ≤ 50% as assessed by echocardiogram.
History of arterial thrombotic disease, specifically including, but not restricted to: Myocardial infarction or unstable angina, cerebrovascular event (CVA) or transient ischemic attack (TIA), Peripheral vascular disease or claudication.
History of venous thromboembolism (e.g. deep venous thrombosis or pulmonary embolism) within 6 months of study entry. Note: Participants enrolled after this window must be on appropriate therapeutic anticoagulation.
History of central serous retinopathy or retinal vein occlusion
Patients with baseline risk factors for central serous retinopathy or retinal vein occlusion such as evidence of new optic disc cupping, evidence of new visual field defects, and intraocular pressure \>21 mmHg are excluded from the trial
History of prior malignancy within 2 years that requires treatment. Patients who are considered NED from a malignancy may be considered on a case by case basis.
Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study
Clareo Health | Trial of Trametinib and Ponatinib in Patients With KRAS Mutant Advanced Non-Small Cell Lung Cancer
