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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDovitinib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 10, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of California, Davis

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: University of California, Davis
Interventions being studied: Drug: Dovitinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California Comprehensive Cancer CenterSacramento, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 10, 2018. Always confirm current availability with the study team.

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