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Maintenance Dovitinib for Colorectal and Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT01888965
Recruitment Status : Terminated (Adverse Event issues.)
First Posted : June 28, 2013
Results First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Georgetown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Pancreas Cancer
Intervention Drug: Dovitinib
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

Period Title: Overall Study
Started 9
Completed 0
Not Completed 9
Reason Not Completed
Adverse Event             5
Lack of Efficacy             4
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  88.9%
>=65 years
1
  11.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants
50.9
(39 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
7
  77.8%
Male
2
  22.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
1.Primary Outcome
Title Biomarker Discovery
Hide Description Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression-free Survival
Hide Description

Time in days from study entry until disease progression or death

Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

Overall Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: days
46
(13 to 287)
3.Secondary Outcome
Title Safety
Hide Description Percent of subjects who experience grade 3/ 4 adverse events
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.
Arm/Group Title Dovitinib
Hide Arm/Group Description:

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: percentage of participants
56
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dovitinib
Hide Arm/Group Description

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.

All-Cause Mortality
Dovitinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dovitinib
Affected / at Risk (%) # Events
Total   5/9 (55.56%)    
Blood and lymphatic system disorders   
neutropenia * 1  1/9 (11.11%)  1
Gastrointestinal disorders   
Gastric obstruction  1  1/9 (11.11%)  1
General disorders   
Fatigue * 1 [1]  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Laryngospasm * 1  1/9 (11.11%)  1
Vascular disorders   
hypertension * 1  1/9 (11.11%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA 10.0
[1]
2 patients = Adjuvant colon cancer; 1 patient = Maintenance colon cancer; 1 patient = Maintenance pancreas cancer
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dovitinib
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Gastrointestinal disorders   
diarrhea * 1  4/9 (44.44%)  5
nausea/vomiting * 1  3/9 (33.33%)  5
General disorders   
fatigue * 1  6/9 (66.67%)  9
Metabolism and nutrition disorders   
hypertriglycerodemia * 1  3/9 (33.33%)  4
Skin and subcutaneous tissue disorders   
hand-foot syndrome * 1  1/9 (11.11%)  1
rash * 1  3/9 (33.33%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedRA 10.0
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: John L Marshall
Organization: Georgetown Lombardi Comprehensive Cancer Center
Phone: 202 444 7064
EMail: marshalj@georgetown.edu
Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT01888965     History of Changes
Other Study ID Numbers: CTK1258AUS16T
Pro063 ( Other Identifier: Georgetown University )
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: February 8, 2016
Results First Posted: July 19, 2016
Last Update Posted: July 19, 2016