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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer, Colorectal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Description:

Measured by an X-Ray and/or a CT and/or an MRI (RECIST criteria)

Outcome 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

Safety Issue:

No

Principal Investigator

Thomas Semrad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis

Authority:

United States: Food and Drug Administration

Study ID:

UCDCC#231

NCT ID:

NCT01676714

Start Date:

February 2013

Completion Date:

October 2016

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Dovitinib
  • Fibroblast Growth Factor Receptor Biomarkers
  • Anti-Vascular Endothelial Growth Factor Therapy
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location

University of California Comprehensive Cancer Center Sacramento, California  95817