Non-small Cell Lung Cancer (NSCLC), Recurrent Clinical Trial
Official title:
A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer
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.
PRIMARY OBJECTIVES:
I. To characterize the safety and tolerability of the combination of erlotinib (erlotinib
hydrochloride) and dovitinib (dovitinib lactate), assessing for toxicity using the Common
Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. To determine the maximum tolerated dose (MTD) of the combination of erlotinib and
dovitinib.
SECONDARY OBJECTIVES:
I. To evaluate overall response rate (ORR), progression free survival (PFS), and overall
survival (OS) of patients receiving the combination of erlotinib and dovitinib, although
this phase will allow for patients who received any number of prior treatments, including
prior treatment with erlotinib.
II. To evaluate the potential impact of dovitinib on erlotinib pharmacokinetics (PK).
OUTLINE: This is a dose-escalation study.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Starting on day 15,
patients also receive dovitinib lactate PO QD on days 1-5 of each week. Treatment continues
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment