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Sunitinib in Never-Smokers With Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT01829217
Recruitment Status : Completed
First Posted : April 11, 2013
Results First Posted : September 3, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Geoffrey Oxnard, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Drug: Sunitinib
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Sunitinib

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Sunitinib
Hide Arm/Group Description

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Sunitinib

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
67
(53 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
7
  53.8%
Male
6
  46.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
1
   7.7%
Not Hispanic or Latino
12
  92.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.
Time Frame ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib
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42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Sunitinib

Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.69
(0.22 to 36.05)
Time Frame Adverse events should be reported from start of study intervention through 30 days after the last dose of study treatment. AEs were assessed through January 23, 2017, approximately 44 months.
Adverse Event Reporting Description Because this drug is commercially available, only grade 3 adverse events are reported here.
 
Arm/Group Title Sunitinib
Hide Arm/Group Description

42 day cycle, taken orally every day for the first 28 days followed by 14 days off

Sunitinib

All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   7/13 (53.85%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%) # Events
Total   9/13 (69.23%)    
Blood and lymphatic system disorders   
Anemia  1  2/13 (15.38%)  6
Febrile neutropenia  1  1/13 (7.69%)  1
Thrombotic thrombocytopenic purpura  1  3/13 (23.08%)  4
Cardiac disorders   
Palpitations  1  1/13 (7.69%)  1
Endocrine disorders   
Endocrine disorders - Other, specify  1  1/13 (7.69%)  3
Hyperthyroidism  1  3/13 (23.08%)  3
Hypothyroidism  1  1/13 (7.69%)  1
Eye disorders   
Dry eye  1  2/13 (15.38%)  3
Eye pain  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/13 (7.69%)  1
Constipation  1  6/13 (46.15%)  8
Diarrhea  1  5/13 (38.46%)  10
Dry mouth  1  2/13 (15.38%)  2
Dyspepsia  1  3/13 (23.08%)  3
Dysphagia  1  1/13 (7.69%)  1
Flatulence  1  1/13 (7.69%)  1
Gastritis  1  1/13 (7.69%)  1
Gastroesophageal reflux disease  1  2/13 (15.38%)  2
Gastrointestinal disorders - Other, specify  1  2/13 (15.38%)  4
Hemorrhoids  1  1/13 (7.69%)  1
Mucositis oral  1  6/13 (46.15%)  11
Nausea  1  6/13 (46.15%)  9
Oral dysesthesia  1  1/13 (7.69%)  1
Oral pain  1  1/13 (7.69%)  1
Rectal hemorrhage  1  1/13 (7.69%)  2
Vomiting  1  4/13 (30.77%)  7
General disorders   
Edema limbs  1  3/13 (23.08%)  3
Flu like symptoms  1  1/13 (7.69%)  1
Localized edema  1  1/13 (7.69%)  1
Malaise  1  1/13 (7.69%)  1
Non-cardiac chest pain  1  2/13 (15.38%)  2
Pain  1  2/13 (15.38%)  3
Fatigue  1  9/13 (69.23%)  20
Hepatobiliary disorders   
Hepatobiliary disorders - Other, specify  1  1/13 (7.69%)  1
Infections and infestations   
Infections and infestations - Other, specify  1  1/13 (7.69%)  3
Mucosal infection  1  1/13 (7.69%)  1
Stoma site infection  1  1/13 (7.69%)  4
Upper respiratory infection  1  1/13 (7.69%)  1
Urinary tract infection  1  1/13 (7.69%)  1
Injury, poisoning and procedural complications   
Bruising  1  3/13 (23.08%)  3
Investigations   
Alanine aminotransferase increased  1  1/13 (7.69%)  3
Alkaline phosphatase increased  1  1/13 (7.69%)  1
Aspartate aminotransferase increased  1  4/13 (30.77%)  5
Blood bilirubin increased  1  1/13 (7.69%)  1
Creatinine increased  1  1/13 (7.69%)  1
Lymphocyte count decreased  1  1/13 (7.69%)  1
Neutrophil count decreased  1  5/13 (38.46%)  11
Platelet count decreased  1  3/13 (23.08%)  8
Weight loss  1  2/13 (15.38%)  4
White blood cell decreased  1  5/13 (38.46%)  11
Metabolism and nutrition disorders   
Anorexia  1  6/13 (46.15%)  9
Dehydration  1  2/13 (15.38%)  3
Glucose intolerance  1  1/13 (7.69%)  1
Hyperglycemia  1  3/13 (23.08%)  6
Hypoalbuminemia  1  1/13 (7.69%)  3
Hypocalcemia  1  1/13 (7.69%)  1
Hypokalemia  1  3/13 (23.08%)  4
Hypomagnesemia  1  2/13 (15.38%)  2
Hyponatremia  1  2/13 (15.38%)  2
Hypophosphatemia  1  3/13 (23.08%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/13 (7.69%)  2
Arthritis  1  1/13 (7.69%)  1
Back pain  1  2/13 (15.38%)  2
Bone pain  1  3/13 (23.08%)  3
Chest wall pain  1  1/13 (7.69%)  1
Muscle weakness upper limb  1  1/13 (7.69%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  1/13 (7.69%)  1
Myalgia  1  1/13 (7.69%)  1
Neck pain  1  1/13 (7.69%)  1
Pain in extremity  1  2/13 (15.38%)  8
Nervous system disorders   
Ataxia  1  1/13 (7.69%)  1
Dizziness  1  2/13 (15.38%)  2
Dysgeusia  1  5/13 (38.46%)  6
Headache  1  2/13 (15.38%)  2
Nervous system disorders - Other, specify  1  1/13 (7.69%)  1
Peripheral motor neuropathy  1  1/13 (7.69%)  1
Psychiatric disorders   
Anxiety  1  1/13 (7.69%)  1
Insomnia  1  2/13 (15.38%)  2
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/13 (7.69%)  1
Bronchopulmonary hemorrhage  1  1/13 (7.69%)  1
Cough  1  6/13 (46.15%)  8
Dyspnea  1  7/13 (53.85%)  7
Epistaxis  1  4/13 (30.77%)  4
Hoarseness  1  1/13 (7.69%)  1
Nasal congestion  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders  1  1/13 (7.69%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  3/13 (23.08%)  4
Palmar-plantar erythrodysesthesia syndrome  1  6/13 (46.15%)  11
Pruritus  1  1/13 (7.69%)  2
Rash acneiform  1  3/13 (23.08%)  3
Skin and subcutaneous tissue disorders - Other, specify  1  1/13 (7.69%)  1
Skin/subcutaneous tissue disorders; Other, specify  1  3/13 (23.08%)  3
Vascular disorders   
Hypertension  1  3/13 (23.08%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
This study was closed to accrual due to slow enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Principal Investigator: Geoffrey Oxnard, MD
Organization: Dana-Farber Cancer Institute
Phone: 617-632-6049
EMail: geoffrey_oxnard@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Geoffrey Oxnard, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01829217     History of Changes
Other Study ID Numbers: 13-086
First Submitted: April 9, 2013
First Posted: April 11, 2013
Results First Submitted: January 30, 2018
Results First Posted: September 3, 2018
Last Update Posted: October 31, 2018