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

NCT01676714 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: UCDCC#231344991CTKI258AUS21T
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small Cell Lung Cancer; Colorectal Cancer

Keywords

Dovitinib; Fibroblast Growth Factor Receptor Biomarkers; Anti-Vascular Endothelial Growth Factor Therapy

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  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.

  Up to 100 months

Secondary Outcomes (3)

• Disease Control Rate

  From start of treatment, up to 8 weeks

• Progression Free Survival

  From start of treatment until the date of death from any cause, assessed up to 100 months

• Number of Patients Who Experienced Treatment Related Toxicities

  Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.

Study Arms (1)

Dovitinib

EXPERIMENTAL

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

Interventions

Dovitinib DRUG

Also known as: TK1258

Dovitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• University of California, Davis: lead
• Novartis: collaborator

Study Sites (1)

University of California Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Analyst
• Organization: University of California Davis

pkaujla@ucdavis.edu

916 734 0294

Study Officials

• Thomas Semrad, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 31, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 10, 2018
• Results First Posted: May 15, 2017

Record last verified: 2018-01

Locations

US (1)