Lung Cancer Clinical Trial
RO5126766 for Patients With Advanced KRAS-Mutant Lung Cancer
The purpose of this study is to test the safety of RO5126766 at different doses to find out what effects, if any, it has on people with advanced lung cancer who have previously received treatment with a PD-1 or PD-L1 inhibitor.
Histologically or cytologically proven diagnosis of advanced NSCLC
Documented presence of KRAS mutation
Prior treatment with a PD-1/L1 inhibitor. Patients who were deemed not eligible for therapy with a PD-1/L1 inhibitor by their treating physician will also be eligible in the dose expansion phase.
Prior treatment with chemotherapy
Able to take oral medications
Measurable and/or evaluable disease (RECIST 1.1) indicator lesion not previously irradiated
Karnofsky performance status (KPS) ≥ 70% (ECOG of 0 or 1 also acceptable)
Age≥ 18 years old
Hematological and biochemical indices within the ranges shown below Hematological and biochemical indices within the ranges shown below (These measurements must be performed within two weeks [Day 14 to Day 1] before the patient is entered into the trial).
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
Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3
Hemoglobin ≥9.0 g/dL
A negative serum pregnancy test obtained within two weeks prior to the administration of the study drug in all women of child bearing potential
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 any bowel disease including abdominal fistula, gastro-intestinal perforation
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 treating physician, 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 3 weeks of starting treatment on protocol (within 6 weeks for for nitrosoureas and mitomycin C)
Radiotherapy within 2 weeks of starting treatment on protocol
Prior treatment with MEK, RAF, or ERK inhibitor(s)
Significant uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
History of clinically significant (as determined by the treating physician) atrial arrhythmia
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
Concurrent congestive heart failure
Prior history of class III/ IV heart failure (New York Heart Association [NYHA]
Myocardial infarction within the last 6 months
Unstable angina or severe obstructive pulmonary disease
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 Uncontrolled hypertension (Diastolic blood pressure > 100 mmHg; Systolic blood pressure > 150 mmHg).
History of central serous retinopathy or retinal vein occlusion
History of prior malignancy within 2 years that requires/ed treatment. Patients who are considered NED from a malignancy may be considered on a case by case basis.
Known active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infections
Patients exposed to CYP3A4 inhibitors within 7 days prior to the first dose and CYP3A4 inducers 7 days prior to the first dose. RO5126766 (CH5126766) is metabolised mainly by CYP3A4 therefore concomitant administration of strong inhibitors and inducers of cytochrome p450 3A4 enzymes is forbidden during study treatment (for a complete list please see Appendix A).
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
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There are 3 Locations for this study
Miami Florida, 33143, United States
New York New York, 10065, United States
Allentown Pennsylvania, 18103, United States
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