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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-Small Cell Lung Cancer
Colorectal Cancer
Intervention Drug: Dovitinib
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dovitinib
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Dovitinib
Hide Arm/Group Description

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.

Dovitinib

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
63
(48 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description 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.
Time Frame Up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:
500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
2.Secondary Outcome
Title Disease Control Rate
Hide Description The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.
Time Frame From start of treatment, up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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 progression or unacceptable toxicity develops.
Arm/Group Title Dovitinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: participants
1
3.Secondary Outcome
Title Progression Free Survival
Time Frame From start of treatment until the date of death from any cause, assessed up to 100 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: months
1.9
(0.23 to 4.1)
4.Secondary Outcome
Title Number of Patients Who Experienced Treatment Related Toxicities
Hide Description 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.
Time Frame Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
Time Frame Up to 30 days after treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dovitinib
Hide Arm/Group Description 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.
All-Cause Mortality
Dovitinib
Affected / at Risk (%)
Total   1/10 (10.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dovitinib
Affected / at Risk (%) # Events
Total   3/10 (30.00%)    
Gastrointestinal disorders   
Esophageal pain  1  1/10 (10.00%)  1
Infections and infestations   
Sepsis  1  1/10 (10.00%)  1
Vascular disorders   
Thrombolic Event  1  1/10 (10.00%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dovitinib
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/10 (30.00%)  3
Gastrointestinal disorders   
Abdominal Pain * 1  2/10 (20.00%)  2
Bloating * 1  2/10 (20.00%)  2
Diarrhea * 1  4/10 (40.00%)  4
Nausea * 1  6/10 (60.00%)  6
Vomiting * 1  3/10 (30.00%)  3
General disorders   
Edema Limbs * 1  2/10 (20.00%)  2
Fatigue * 1  9/10 (90.00%)  9
Malaise * 1  2/10 (20.00%)  2
Investigations   
ALT Increased  1  5/10 (50.00%)  5
Alkaline phosphatase increased  1  8/10 (80.00%)  8
AST increased  1  5/10 (50.00%)  5
Blood Bilirubin Increased  1  5/10 (50.00%)  5
Cholesterol High  1  2/10 (20.00%)  2
GCT Increased  1  6/10 (60.00%)  6
Lymphocyte count decreased  1  4/10 (40.00%)  4
Other - LDH Increased  1  2/10 (20.00%)  2
Weight Loss  1  5/10 (50.00%)  5
Metabolism and nutrition disorders   
Anorexia  1  8/10 (80.00%)  8
Dehydration  1  2/10 (20.00%)  2
Hypoalbuminemia  1  6/10 (60.00%)  6
Hypoatremia  1  4/10 (40.00%)  4
Hypertriglyceridemia  1  4/10 (40.00%)  4
Musculoskeletal and connective tissue disorders   
General Muscle Weakness  1  5/10 (50.00%)  5
Psychiatric disorders   
Insomnia  1  2/10 (20.00%)  2
Skin and subcutaneous tissue disorders   
Dry Skin * 1  2/10 (20.00%)  2
Vascular disorders   
Hypertension  1  1/10 (10.00%)  1
Hypotension  1  2/10 (20.00%)  2
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Analyst
Organization: University of California Davis
Phone: 916 734 0294
EMail: pkaujla@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01676714     History of Changes
Other Study ID Numbers: UCDCC#231
344991 ( Other Grant/Funding Number: UC Davis )
CTKI258AUS21T ( Other Grant/Funding Number: Novartis )
First Submitted: August 27, 2012
First Posted: August 31, 2012
Results First Submitted: March 17, 2017
Results First Posted: May 15, 2017
Last Update Posted: January 10, 2018