Spots Global Cancer Trial Database for Phase 1 Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer (NSCLC)

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Trial Identification

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

Official Title: A Phase I Study of Erlotinib and Dovitinib (TKI258) in Advanced Non-small Cell Lung Cancer

Study ID: NCT01515969

Conditions

Non-small Cell Lung Cancer (NSCLC), Recurrent

Non-small Cell Lung Cancer (NSCLC), Stage IV

Interventions

Erlotinib hydrochloride

Dovitinib lactate

Study Description

Brief Summary: 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.

Detailed Description: 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.