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Trial record 8 of 128 for:    Adenoid Cystic Carcinoma

Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

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ClinicalTrials.gov Identifier: NCT01558661
Recruitment Status : Completed
First Posted : March 20, 2012
Results First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenoid Cystic Carcinoma
Intervention Drug: AG-013736 (AXITINIB)
Enrollment 33
Recruitment Details Protocol Open to Accrual 03-15-2012, Protocol Closed to Accrual 08-27-2013, Primary Completion Date 08-25-2016, Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Period Title: Overall Study
Started 33
First Stage 18
Second Stage 15
Completed 33
Not Completed 0
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants
56
(39 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female 15
Male 18
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Hispanic or Latino
6
  18.2%
Not Hispanic or Latino
27
  81.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
  12.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
28
  84.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Overall Response Rate
Hide Description Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not for Progression Free Survival.
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description:
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
0
   0.0%
Partial Response
3
   9.1%
Stable Disease
25
  75.8%
Progressive Disease
4
  12.1%
Non-evaluable
1
   3.0%
2.Secondary Outcome
Title Median Progression-free Survival (PFS).
Hide Description Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description:
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(5.3 to 9.1)
3.Secondary Outcome
Title MYB Immunohistochemistry (IHC)
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
MYB immunohistochemistry (IHC) was carried out on tumors from 33 patients. MYB quantification was assessed as: 2+ for strong staining in >50% of cancer cells, 1+ for weak or strong staining in <50% of the cells and 0 for <5% staining.
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description:
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
MYB IHC Testing Not Done
7
  21.2%
MYB IHC Score 0
13
  39.4%
MYB IHC Score +1
8
  24.2%
MYB IHC Score +2
5
  15.2%
4.Secondary Outcome
Title Number of Participants With Next Generation Sequencing (NGS)
Hide Description Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description:
This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
Overall Number of Participants Analyzed 33
Measure Type: Count of Participants
Unit of Measure: Participants
No NGS sequencing
22
  66.7%
NGS sequencing
11
  33.3%
Time Frame Up to 2 years
Adverse Event Reporting Description Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
 
Arm/Group Title AG-013736 (AXITINIB)
Hide Arm/Group Description This is a single-arm phase II study evaluating the clinical efficacy of axitinib in the treatment of patients with progressive, recurrent/metastatic adenoid cystic carcinoma (ACC).
All-Cause Mortality
AG-013736 (AXITINIB)
Affected / at Risk (%)
Total   25/33 (75.76%) 
Show Serious Adverse Events Hide Serious Adverse Events
AG-013736 (AXITINIB)
Affected / at Risk (%)
Total   10/33 (30.30%) 
Cardiac disorders   
Sinus bradycardia   1/33 (3.03%) 
Eye disorders   
Corneal Ulcer   1/33 (3.03%) 
General disorders   
Death NOS   2/33 (6.06%) 
Fatigue   1/33 (3.03%) 
Fever   1/33 (3.03%) 
Non-cardiac chest pain   1/33 (3.03%) 
Infections and infestations   
Infections and infestations - Other   1/33 (3.03%) 
Lung infection   2/33 (6.06%) 
Urinary tract infection   1/33 (3.03%) 
Injury, poisoning and procedural complications   
Fracture   1/33 (3.03%) 
Investigations   
Alanine aminotransferase increased   2/33 (6.06%) 
Alkaline Phosphatase Increased   2/33 (6.06%) 
Aspartate aminotransferase increased   2/33 (6.06%) 
Blood bilirubin increased   3/33 (9.09%) 
Weight loss   1/33 (3.03%) 
Metabolism and nutrition disorders   
Hypoalbuminemia   2/33 (6.06%) 
Hypocalcemia   1/33 (3.03%) 
Hypokalemia   1/33 (3.03%) 
Hyponatremia   1/33 (3.03%) 
Musculoskeletal and connective tissue disorders   
Neck Pain   1/33 (3.03%) 
Nervous system disorders   
Intracranial hemorrhage   1/33 (3.03%) 
Lethargy   1/33 (3.03%) 
Seizure   1/33 (3.03%) 
Psychiatric disorders   
Confusion   1/33 (3.03%) 
Respiratory, thoracic and mediastinal disorders   
Cough   1/33 (3.03%) 
Dyspnea   2/33 (6.06%) 
Vascular disorders   
Hypertension   1/33 (3.03%) 
Hypotension   1/33 (3.03%) 
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 5%
AG-013736 (AXITINIB)
Affected / at Risk (%)
Total   33/33 (100.00%) 
Blood and lymphatic system disorders   
Anemia   11/33 (33.33%) 
Endocrine disorders   
Hypothyroidism   7/33 (21.21%) 
Gastrointestinal disorders   
Diarrhea   18/33 (54.55%) 
Nausea   16/33 (48.48%) 
Oral pain   14/33 (42.42%) 
Mucositis oral   12/33 (36.36%) 
Dysphagia   8/33 (24.24%) 
Constipation   7/33 (21.21%) 
Vomiting   6/33 (18.18%) 
Abdominal pain   5/33 (15.15%) 
Dyspepsia   5/33 (15.15%) 
Gastroesophageal reflux disease   2/33 (6.06%) 
General disorders   
Fatigue   30/33 (90.91%) 
Pain   4/33 (12.12%) 
Investigations   
Weight loss   18/33 (54.55%) 
Alanine aminotransferase increased   15/33 (45.45%) 
Alkaline phosphatase increased   14/33 (42.42%) 
Aspartate aminotransferase increased   9/33 (27.27%) 
Platelet count decreased   9/33 (27.27%) 
White blood cell decreased   9/33 (27.27%) 
Blood bilirubin increased   7/33 (21.21%) 
Hemoglobin increased   6/33 (18.18%) 
Serum amylase increased   2/33 (6.06%) 
Metabolism and nutrition disorders   
Anorexia   18/33 (54.55%) 
Hyperglycemia   18/33 (54.55%) 
Hypoglycemia   7/33 (21.21%) 
Hypoalbuminemia   6/33 (18.18%) 
Hyponatremia   5/33 (15.15%) 
Hyperkalemia   3/33 (9.09%) 
Hypernatremia   3/33 (9.09%) 
Hypokalemia   3/33 (9.09%) 
Hypophosphatemia   3/33 (9.09%) 
Hypocalcemia   2/33 (6.06%) 
Musculoskeletal and connective tissue disorders   
Myalgia   13/33 (39.39%) 
Arthralgia   8/33 (24.24%) 
Pain in extremity   4/33 (12.12%) 
Chest wall pain   2/33 (6.06%) 
Nervous system disorders   
Headache   5/33 (15.15%) 
Peripheral sensory neuropathy   5/33 (15.15%) 
Renal and urinary disorders   
Proteinuria   4/33 (12.12%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis   5/33 (15.15%) 
Hoarseness   5/33 (15.15%) 
Dyspnea   3/33 (9.09%) 
Sore throat   3/33 (9.09%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysesthesia syndrome   17/33 (51.52%) 
Rash maculo-papular   5/33 (15.15%) 
Alopecia   3/33 (9.09%) 
Dry skin   2/33 (6.06%) 
Vascular disorders   
Hypertension   32/33 (96.97%) 
Indicates events were collected by 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: Dr. Alan Ho, MD, PhD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4235
EMail: hoa@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01558661     History of Changes
Other Study ID Numbers: 12-004
First Submitted: March 16, 2012
First Posted: March 20, 2012
Results First Submitted: July 17, 2017
Results First Posted: November 28, 2017
Last Update Posted: November 28, 2017