Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)

Stopped early · Phase 1

Conditions studied: Non-small Cell Lung Cancer (NSCLC), Recurrent, Non-small Cell Lung Cancer (NSCLC), Stage IV

In brief

This phase I trial studies the side effects and best dose of giving erlotinib and dovitinib together to treat patients with metastatic non-small cell lung cancer. Erlotinib blocks the epidermal growth factor receptor (EGFR) and has known activity in non-small cell lung cancer and dovitinib blocks the fibroblast growth factor receptor (FGFR) and other targets which may be important to treat lung cancer. The combination of both drugs may work better than either drug alone, but may also have increased side effects. This trial will look at the side effects of combining the drugs and look for how effective the combination may be.

Key facts

Study ID: NCT01515969
Run by: Heather Wakelee
People needed: 9
Starts: 2012-07-01
Expected to finish: 2014-12-01
Last updated by the study team: 2016-07-12

Who can join

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

You may qualify if…

Histologically-confirmed metastatic non-small cell lung cancer
One or more primary or metastatic lesions measurable in at least one dimension by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria (v1.1) within 4 weeks prior to entry of study
Patients who have failed any number of prior therapies, including those previously treated with erlotinib
Life expectancy > 2 months
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Absolute neutrophil count (ANC) >= 1.5 x 10\^9/L (>= 1500/mm\^3)
Platelets (PLT) >= 100,000/mm\^3
Hemoglobin (Hgb) >= 9 g/dL
Serum creatinine =< 1.5 x upper limit of normal (ULN)
Serum bilirubin =< 1.5 x ULN (regardless of whether liver metastases are present at baseline)
Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) =< 3.0 x ULN (regardless of whether liver metastases are present at baseline)
Ability to understand and the willingness to provide verbal and written informed consent
Patients - both males and females- with reproductive potential (i.e. menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study; women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration

You may not qualify if…

Patients who have received the last administration of chemotherapy or immunotherapy =< the timeframe defined below after the end of the cycle of the last treatment, prior to starting study drug, or who have not recovered from the side effects of such therapy:
Patients who have received the last administration of chemotherapy/immunotherapy in a daily schedule =< 7 days prior to starting study drug
Patients who have received the last administration of chemotherapy/immunotherapy in a weekly schedule =< 2 weeks prior to starting study drug
Patients who have received the last administration of chemotherapy/immunotherapy in a 2-weekly schedule =< 3 weeks prior to starting study drug
Patients who have received the last administration of chemotherapy/immunotherapy in a 3-weekly schedule =< 4 weeks prior to starting study drug
Patients who have received the last administration of chemotherapy/immunotherapy in a 4-weekly schedule =< 5 weeks prior to starting study drug
Patients who have received the last administration of nitrosourea, mitomycin-C =< 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients who have received wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =< 4 weeks or limited field radiation for palliation =< 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have undergone major surgery =< 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
If history of other primary cancer, subject will be eligible only if she or he has:
Curatively resected non-melanomatous skin cancer, basal cell carcinoma, squamous cell carcinoma
Curatively treated cervical carcinoma in situ
Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years
Subjects known to have chronic or active hepatitis B or C infection with impaired hepatic function (ineligible if AST and ALT > 2.5 x ULN)
History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results
Patients who continue to smoke (given that smoking decreases serum levels of erlotinib)
Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to enrollment
Any of the following concurrent severe and/or uncontrolled medical conditions within 6 months of enrollment which could compromise participation in the study:
Unstable angina pectoris
Uncontrolled hypertension defined by a systolic blood pressure (SBP) >= 160 mm Hg and/or diastolic blood pressure (DBP) >= 100 mm Hg, with or without anti-hypertensive medication; initiation or adjustment of antihypertensive medication(s) is allowed prior to study entry
Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) < 50% or lower limit of normal (whichever is higher) or multiple gated acquisition scan (MUGA) < 45% or lower limit of normal (whichever is higher)
Myocardial infarction
Serious uncontrolled ventricular arrhythmia
Clinically significant resting bradycardia
Uncontrolled diabetes

Where it is running

Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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