Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Colorectal Cancer

In brief

The purpose of this study is to find out if dovitinib is an effective treatment for patients with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on anti-vascular endothelial growth factor (VEGF) treatment.

Key facts

Study ID: NCT01676714
Run by: University of California, Davis
People needed: 10
Starts: 2013-02-01
Expected to finish: 2016-06-01
Last updated by the study team: 2018-01-10

Who can join

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

You may qualify if…

Histologically confirmed non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
Any number of prior treatment regimens are allowed
Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF therapies, contact the principal investigator.
Last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment.
Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment.
Willingness to consent to research biopsy
Measurable disease by RECIST 1.1 criteria
Available tumor site amenable to core needle biopsy as determined by the treating investigator. Any questions regarding suitability of site for biopsy will be adjudicated by the principal investigator.
Zubrod (ECOG) performance status 0 or 1
Age ≥ 18 years old
Patients who give a written informed consent
Patients must have the following laboratory values:
Platelets ≥ 100 x 109/L
Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin > 9 g/dL
Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN
ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)
Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN

You may not qualify if…

Patients with known brain metastases
Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer
Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not resolved to NCI CTCAE grade 1 or less.
Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have side effects that have not resolved to NCI CTCAE grade 1 or less.
Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy or who have not recovered from radiotherapy toxicities
Patients who have undergone major surgery, open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
Impaired cardiac function or clinically significant cardiac diseases
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Known diagnosis of human immunodeficiency virus infection
Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
Other concurrent severe and/or uncontrolled concomitant medical conditions
Pregnant or breast-feeding women
Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception.
Fertile males not willing to use contraception, as stated above
Patients unwilling or unable to comply with the protocol

Where it is running

University of California Comprehensive Cancer Center — Sacramento, California, United States

Full record on ClinicalTrials.gov

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