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

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ClinicalTrials.gov Identifier: NCT01676714
Recruitment Status : Completed
First Posted : August 31, 2012
Results First Posted : May 15, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE August 27, 2012
First Posted Date  ICMJE August 31, 2012
Results First Submitted Date  ICMJE March 17, 2017
Results First Posted Date  ICMJE May 15, 2017
Last Update Posted Date January 10, 2018
Study Start Date  ICMJE February 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2017)
Overall Response Rate [ Time Frame: Up to 100 months ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
Overall Response [ Time Frame: From start of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
Measured by an X-Ray and/or a CT and/or an MRI (RECIST criteria)
Change History Complete list of historical versions of study NCT01676714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • Disease Control Rate [ Time Frame: From start of treatment, up to 8 weeks ]
    The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.
  • Progression Free Survival [ Time Frame: From start of treatment until the date of death from any cause, assessed up to 100 months ]
    The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
  • Number of Patients Who Experienced Treatment Related Toxicities [ Time Frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment. ]
    Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • Disease Control Rate [ Time Frame: Measured at 8 weeks ]
    The total proportion of patients who demonstrate a response to treatment. Measured by RECIST criteria.
  • Progression Free Survival [ Time Frame: From start of treatment until the date of death from any cause, assessed up to 100 months ]
    The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse.
  • Toxicity [ Time Frame: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment. ]
    Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
Official Title  ICMJE Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy
Brief 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.
Detailed Description The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory initial observations of the relationship between FGF signaling alterations and the clinical activity of dovitinib. This trial is expected to provide key biologic information that will inform the clinical development of dovitinib and provide initial evaluation of the analytic characteristics of these potential predictive biomarkers of its efficacy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
Intervention  ICMJE Drug: Dovitinib
Other Name: TK1258
Study Arms  ICMJE Experimental: Dovitinib
500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Intervention: Drug: Dovitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2012)
35
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion 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

Exclusion 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01676714
Other Study ID Numbers  ICMJE UCDCC#231
344991 ( Other Grant/Funding Number: UC Davis )
CTKI258AUS21T ( Other Grant/Funding Number: Novartis )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Thomas Semrad, MD University of California, Davis
PRS Account University of California, Davis
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP