Clinical Trials Directory

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.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : dovitinib lactate
  • drug : erlotinib hydrochloride

Phase: Phase 1

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- 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

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Contact information

Primary Contact:

Lisa Zhou 6507364112

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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