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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, Davis
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01676714
First received: August 27, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Colorectal Cancer
Drug: Dovitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Measured by an X-Ray and/or a CT and/or an MRI (RECIST criteria)


Secondary Outcome Measures:
  • Disease Control Rate [ Time Frame: Measured at 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 35
Study Start Date: February 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Dovitinib
Other Name: TK1258

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676714

Contacts
Contact: Clinical Trials Navigator 916-734-3089

Locations
United States, California
University of California Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Novartis
Investigators
Principal Investigator: Thomas Semrad, MD University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01676714     History of Changes
Other Study ID Numbers: UCDCC#231, CTKI258AUS21T
Study First Received: August 27, 2012
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, Davis:
Dovitinib
Fibroblast Growth Factor Receptor Biomarkers
Anti-Vascular Endothelial Growth Factor Therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Endothelial Growth Factors
Mitogens
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014