Binimetinib With Docetaxel in Treating Patients With Previously Treated, Stage IV Non-small Cell Lung Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer

In brief

This phase Ib trial studies the safety and best dose of binimetinib when given in combination with docetaxel in treating patients with previously treated, stage IV non-small cell lung cancer. Binimetinib and docetaxel may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT02451865
Run by: Jonsson Comprehensive Cancer Center
People needed: 0
Starts: 2016-06-01
Expected to finish: 2019-06-01
Last updated by the study team: 2020-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed written informed consent
A histologically or cytologically confirmed diagnosis of stage IV NSCLC
Must have progressed on at least one prior line of platinum-based therapy for stage IV NSCLC (excluding docetaxel or mitogen activated protein kinase kinase [MEK] inhibitors)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Measurable disease defined by RECIST criteria
Ability to provide adequate tissue from archival tumor specimen; confirmation of adequate tissue is required prior to enrollment
In expansion cohort only: patient's kirsten rat sarcoma viral oncogene homolog (KRAS) mutational status must be known prior to enrollment
Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L
Hemoglobin (Hgb) >= 9 g/dL without transfusions
Platelets (PLT) >= 100 x 10\^9/L without transfusions
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
Total bilirubin =< 1.5 x ULN
Creatinine =< 1.5 mg/dL
Left ventricular ejection fraction (LVEF) >= 45% as determined by a multigated acquisition (MUGA) scan or echocardiogram, and QTc interval =< 480ms
Able to take and retain oral medications
Patient is deemed by the investigator to have the initiative and means to be compliant with the protocol (treatment and follow-up)
Negative serum beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) performed locally within 72 hours (hrs) prior to first dose

You may not qualify if…

History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
History of Gilbert syndrome
Previous or concurrent malignancy within the last 3 years with the exception of adequately treated skin basal or squamous cell with adequate wound healing
Prior therapy with a MEK-inhibitor or docetaxel for metastatic non-small cell lung cancer (docetaxel in the adjuvant setting will be allowed)
Epidermal growth factor receptor (EGFR) mutant and/or anaplastic lymphoma receptor tyrosine kinase (ALK) gene rearranged tumor
Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following within 6 months of enrollment: myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting, symptomatic chronic heart failure, clinically significant cardiac arrhythmias and/or conduction (except atrial fibrillation and paroxysmal supraventricular tachycardia)
Uncontrolled arterial hypertension despite appropriate medical therapy
Known positive serology for human immunodeficiency virus (HIV), active hepatitis B, and/or active hepatitis C infection
Neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy)
Subjects planning on embarking on a new strenuous exercise regimen after first dose of study treatment that can result in significant increases in plasma CK levels
Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption)
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to concerns regarding safety or compliance with clinical study procedures
Patients who have undergone major surgery =< 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure
Pregnant or lactating women
Women of child-bearing potential defined as all women physiologically capable of becoming pregnant who are unwilling to use highly effective methods of contraception throughout the study and 15 days after study drug discontinuation
Sexually active males unless they are willing to use a condom during intercourse while taking the drug and for 15 days after stopping treatment and are willing to forego fathering a child in this period; a condom is required to be used also by vasectomized men
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Grade II or greater neuropathy at baseline
Symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 14 days) or brain metastases that have not been previously treated
Treatment with prior chemotherapy, monoclonal antibodies, other protein or peptide therapeutics or anticancer immunotherapy within 21 days of the first dose of study drug
Treatment with prior radiotherapy within 28 days of initiating study drug; however, if the radiation portal covered =< 10% of the bone marrow reserve, the patient may be enrolled without respect to the end date of radiotherapy

Where it is running

UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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