Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sunitinib in Treating Patients With Advanced Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00392444
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : December 13, 2013
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Malignant Mesothelioma
Recurrent Malignant Mesothelioma
Intervention Drug: sunitinib malate
Enrollment 39
Recruitment Details This study was centrally activated on November 10, 2006 and the study was closed to accrual on September 10, 2010. Patients were recruited from 9 cancer clinics in Canada
Pre-assignment Details  
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
1 patient was cancelled due to intercurrent illness and another 3 were found to be ineligible after review. Those 4 patients were excluded from all analyses.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
66
(48 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
6
  17.1%
Male
29
  82.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 35 participants
35
1.Primary Outcome
Title Objective Response (Partial and Complete) Per RECIST
Hide Description Number of patients who had objective responses after radiology review
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 cancelled patient and 4 ineligible patients were excluded from analysis.
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Sunitinib Malate)
Hide Arm/Group Description Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   21/35 (60.00%) 
Blood and lymphatic system disorders   
Hospitalization for Grade 3 hemorrhage  1  1/35 (2.86%) 
Hospitalized for grade 3 edema  1  1/35 (2.86%) 
Cardiac disorders   
Grade 2 left ventricular systolic dysfunction  1  1/35 (2.86%) 
Grade 2 hypertension  1  1/35 (2.86%) 
Ear and labyrinth disorders   
Grade 2 tinnitus  1  1/35 (2.86%) 
Endocrine disorders   
Grade 2 Hypothyroidism  1  1/35 (2.86%) 
Gastrointestinal disorders   
Grade 2 Esophagitis  1  1/35 (2.86%) 
Hospitalized for grade 3 diarrhea  1  2/35 (5.71%) 
Grade 2 flatulence  1  1/35 (2.86%) 
Hospitalization for Grade 3 dehydration  1  1/35 (2.86%) 
General disorders   
Hospitalization for Grade 3 fatigue  1  1/35 (2.86%) 
Hospitalization for Grade 2 fatigue  1  1/35 (2.86%) 
Death not associated with CTCAE term  1  2/35 (5.71%) 
Hospitalization for grade 3 pain  1  1/35 (2.86%) 
Infections and infestations   
Grade 3 infection with normal ANC  1  1/35 (2.86%) 
Grade 2 Infection with normal ANC  1  1/35 (2.86%) 
Grade 5 infection with unknown ANC  1  1/35 (2.86%) 
Investigations   
Grade 3 hyperkalemia  1  1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hospitalization for grade 4 malignant pericardial effusion  1  1/35 (2.86%) 
Nervous system disorders   
Grade 2 dizziness  1  1/35 (2.86%) 
Hospitalized for grade 2 seizure  1  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders   
Hospitalization for Grade 3 bronchopulmonary NOS  1  1/35 (2.86%) 
Hospitalization for Grade 3 dyspnea  1  3/35 (8.57%) 
Hospitalization for Grade 3 cough  1  1/35 (2.86%) 
Grade 4 pulmonary emboli  1  1/35 (2.86%) 
Hospitalized for grade 2 cough  1  1/35 (2.86%) 
Hospitalized for grade 3 pulmonary/upper respiratory other - subcutaneous emphysema  1  1/35 (2.86%) 
Hospitalization for grade 4 obstruction/stenosis of airway - Bronchus  1  1/35 (2.86%) 
Hospitalization for pleural effusion grade 3  1  1/35 (2.86%) 
Hospitalization for Grade 4 dyspnea  1  1/35 (2.86%) 
Vascular disorders   
Grade 3 thrombosis/thrombus/embolism  1  1/35 (2.86%) 
Grade 4 thrombocytopenia  1  1/35 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Sunitinib Malate)
Affected / at Risk (%)
Total   35/35 (100.00%) 
Blood and lymphatic system disorders   
Hemorrhage pulmonary Bronchopulmonary NOS  1  4/35 (11.43%) 
Hemorrhage pulmonary Nose  1  14/35 (40.00%) 
Hemorrhage - Other  1  2/35 (5.71%) 
Edema: limb  1  9/35 (25.71%) 
Edema: trunk/genital  1  4/35 (11.43%) 
Cardiac disorders   
Hypertension  1  10/35 (28.57%) 
Endocrine disorders   
Hypothyroidism  1  2/35 (5.71%) 
Eye disorders   
Ocular - Other  1  2/35 (5.71%) 
Gastrointestinal disorders   
Anorexia  1  23/35 (65.71%) 
Constipation  1  18/35 (51.43%) 
Dehydration  1  2/35 (5.71%) 
Diarrhea  1  18/35 (51.43%) 
Distension  1  4/35 (11.43%) 
Dry mouth  1  5/35 (14.29%) 
Flatulence  1  4/35 (11.43%) 
Heartburn  1  10/35 (28.57%) 
Mucositis (clinical exam) Oral cavity  1  17/35 (48.57%) 
Mucositis (functional/symptomatic) Oral cavity  1  4/35 (11.43%) 
Nausea  1  24/35 (68.57%) 
Taste alteration  1  19/35 (54.29%) 
Vomiting  1  11/35 (31.43%) 
GI - Other  1  2/35 (5.71%) 
General disorders   
Fatigue  1  34/35 (97.14%) 
Fever  1  4/35 (11.43%) 
Insomnia  1  11/35 (31.43%) 
Rigors/chills  1  4/35 (11.43%) 
Sweating  1  8/35 (22.86%) 
Pain Abdomen NOS  1  17/35 (48.57%) 
Pain Back  1  10/35 (28.57%) 
Pain Bone  1  2/35 (5.71%) 
Pain Chest/thorax NOS  1  19/35 (54.29%) 
Pain Extremity-limb  1  4/35 (11.43%) 
Pain Head/headache  1  10/35 (28.57%) 
Pain Joint  1  8/35 (22.86%) 
Pain Muscle  1  5/35 (14.29%) 
Pain Oral cavity  1  2/35 (5.71%) 
Pain Throat/pharynx/larynx  1  4/35 (11.43%) 
Pain Tumor pain  1  6/35 (17.14%) 
Pain - Other  1  2/35 (5.71%) 
Flu-like syndrome  1  3/35 (8.57%) 
Immune system disorders   
Rhinitis  1  2/35 (5.71%) 
Infections and infestations   
Infection with normal ANC Bronchus  1  2/35 (5.71%) 
Infection with normal ANC Lung  1  2/35 (5.71%) 
Infection with normal ANC Skin  1  2/35 (5.71%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness Extremity-lowe  1  2/35 (5.71%) 
Nervous system disorders   
Cognitive disturbance  1  2/35 (5.71%) 
Confusion  1  2/35 (5.71%) 
Dizziness  1  10/35 (28.57%) 
Involuntary movement  1  3/35 (8.57%) 
Mood alteration Anxiety  1  5/35 (14.29%) 
Mood alteration Depression  1  2/35 (5.71%) 
Neuropathy-motor  1  2/35 (5.71%) 
Neuropathy-sensory  1  11/35 (31.43%) 
Renal and urinary disorders   
Urinary frequency  1  2/35 (5.71%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  24/35 (68.57%) 
Dyspnea  1  31/35 (88.57%) 
Pleural effusion  1  3/35 (8.57%) 
Pulmonary - Other  1  2/35 (5.71%) 
Skin and subcutaneous tissue disorders   
Acne  1  3/35 (8.57%) 
Bruising  1  2/35 (5.71%) 
Dry skin  1  6/35 (17.14%) 
Hand-foot  1  8/35 (22.86%) 
Hypopigmentation  1  3/35 (8.57%) 
Pruritus  1  2/35 (5.71%) 
Rash  1  12/35 (34.29%) 
Dermatology - Other  1  7/35 (20.00%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  2/35 (5.71%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Scott Laurie
Organization: The Ottawa Hospital Cancer Centre
Phone: 613-737-7700 ext 70175
EMail: slaurie@toh.on.ca
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00392444    
Other Study ID Numbers: NCI-2009-00693
NCI-2009-00693 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000652058
NCIC-183 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-183 ( Other Identifier: CTEP )
First Submitted: October 25, 2006
First Posted: October 26, 2006
Results First Submitted: October 21, 2013
Results First Posted: December 13, 2013
Last Update Posted: May 21, 2014