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Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer

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ClinicalTrials.gov Identifier: NCT01255137
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adrenal Cortex Neoplasms
Intervention Drug: Axitinib
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Adrenal Cortex Neoplasms
Hide Arm/Group Description

Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.

Axitinib : 5 mg tab orally twice a day with food every 28 days

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Adrenal Cortex Neoplasms
Hide Arm/Group Description

Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.

Axitinib : 5 mg tab orally twice a day with food every 28 days

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  76.9%
>=65 years
3
  23.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
53.89  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
10
  76.9%
Male
3
  23.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
  92.3%
Unknown or Not Reported
1
   7.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  30.8%
White
9
  69.2%
More than one race
0
   0.0%
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 Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)
Hide Description Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameter. Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: the appearance of one or more new lesions is also considered progression). Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum diameters while on study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adrenal Cortex Neoplasms
Hide Arm/Group Description:

Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.

Axitinib : 5 mg tab orally twice a day with food every 28 days

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
Complete Response 0
Partial Response 0
Progression 13
Stable Disease 0
2.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.
Time Frame 3/2/11 - 8/2/12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adrenal Cortex Neoplasms
Hide Arm/Group Description:

Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.

Axitinib : 5 mg tab orally twice a day with food every 28 days

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: Participants
13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adrenal Cortex Neoplasms
Hide Arm/Group Description

Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.

Axitinib : 5 mg tab orally twice a day with food every 28 days

All-Cause Mortality
Adrenal Cortex Neoplasms
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Adrenal Cortex Neoplasms
Affected / at Risk (%) # Events
Total   2/13 (15.38%)    
Endocrine disorders   
Adrenal insufficiency  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Nausea  1  1/13 (7.69%)  1
Vomiting  1  1/13 (7.69%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/13 (7.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adrenal Cortex Neoplasms
Affected / at Risk (%) # Events
Total   13/13 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  8/13 (61.54%)  14
Cardiac disorders   
Sinus bradycardia  1  1/13 (7.69%)  1
Ear and labyrinth disorders   
Ear pain  1  1/13 (7.69%)  1
Hearing impaired  1  1/13 (7.69%)  1
Endocrine disorders   
Cushingoid  1  1/13 (7.69%)  2
Hypothyroidism  1  1/13 (7.69%)  1
Eye disorders   
Blurred vision  1  1/13 (7.69%)  1
Gastrointestinal disorders   
Abdominal pain  1  6/13 (46.15%)  10
Anal hemorrhage  1  1/13 (7.69%)  1
Cheilitis  1  1/13 (7.69%)  1
Colonic hemorrhage  1  1/13 (7.69%)  1
Constipation  1  5/13 (38.46%)  5
Diarrhea  1  2/13 (15.38%)  9
Dyspepsia  1  1/13 (7.69%)  1
Esophageal hemorrhage  1  1/13 (7.69%)  1
Gastroesophageal reflux disease  1  1/13 (7.69%)  1
Gastrointestinal pain  1  1/13 (7.69%)  1
Mucositis oral  1  1/13 (7.69%)  1
Nausea  1  7/13 (53.85%)  11
Oral dysesthesia  1  1/13 (7.69%)  1
Pancreatitis  1  1/13 (7.69%)  1
Vomiting  1  3/13 (23.08%)  3
General disorders   
Edema face  1  1/13 (7.69%)  1
Edema limbs  1  1/13 (7.69%)  1
Fatigue  1  7/13 (53.85%)  13
Fever  1  2/13 (15.38%)  2
Gait disturbance  1  2/13 (15.38%)  2
Immune system disorders   
Autoimmune disorder  1  1/13 (7.69%)  1
Infections and infestations   
Upper respiratory infection  1  2/13 (15.38%)  3
Injury, poisoning and procedural complications   
Bruising  1  1/13 (7.69%)  1
Investigations   
Activated partial thromboplastin time prolonged  1  2/13 (15.38%)  2
Alanine aminotransferase increased  1  4/13 (30.77%)  5
Alkaline phosphatase increased  1  5/13 (38.46%)  8
Aspartate aminotransferase increased  1  5/13 (38.46%)  10
Blood bilirubin increased  1  2/13 (15.38%)  2
CPK increased  1  1/13 (7.69%)  1
Creatinine increased  1  4/13 (30.77%)  7
Lipase increased  1  2/13 (15.38%)  6
Lymphocyte count decreased  1  6/13 (46.15%)  10
Platelet count decreased  1  1/13 (7.69%)  1
Weight loss  1  2/13 (15.38%)  3
White blood cell decreased  1  1/13 (7.69%)  1
Metabolism and nutrition disorders   
Anorexia  1  4/13 (30.77%)  10
Dehydration  1  1/13 (7.69%)  1
Hypercalcemia  1  3/13 (23.08%)  4
Hypermagnesemia  1  7/13 (53.85%)  7
Hyperuricemia  1  2/13 (15.38%)  2
Hypoalbuminemia  1  7/13 (53.85%)  13
Hypocalcemia  1  2/13 (15.38%)  2
Hypokalemia  1  3/13 (23.08%)  3
Hypomagnesemia  1  2/13 (15.38%)  4
Hyponatremia  1  3/13 (23.08%)  10
Hypophosphatemia  1  6/13 (46.15%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia  1  5/13 (38.46%)  8
Arthritis  1  1/13 (7.69%)  1
Back pain  1  2/13 (15.38%)  3
Bone pain  1  1/13 (7.69%)  1
Chest wall pain  1  3/13 (23.08%)  4
Muscle weakness lower limb  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%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  1/13 (7.69%)  2
Nervous system disorders   
Dizziness  1  2/13 (15.38%)  4
Headache  1  2/13 (15.38%)  3
Peripheral sensory neuropathy  1  2/13 (15.38%)  2
Psychiatric disorders   
Anxiety  1  1/13 (7.69%)  1
Confusion  1  1/13 (7.69%)  1
Depression  1  1/13 (7.69%)  1
Insomnia  1  1/13 (7.69%)  1
Renal and urinary disorders   
Hematuria  1  1/13 (7.69%)  2
Urinary frequency  1  2/13 (15.38%)  2
Urinary incontinence  1  1/13 (7.69%)  1
Urinary tract pain  1  1/13 (7.69%)  1
Urinary urgency  1  1/13 (7.69%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/13 (15.38%)  2
Dyspnea  1  3/13 (23.08%)  3
Hoarseness  1  4/13 (30.77%)  4
Voice alteration  1  1/13 (7.69%)  2
Skin and subcutaneous tissue disorders   
Dry skin  1  2/13 (15.38%)  2
Hyperhidrosis  1  1/13 (7.69%)  1
Pain of skin  1  1/13 (7.69%)  1
Palmar-plantar erythrodysesthesia syndrome  1  2/13 (15.38%)  5
Rash maculo-papular  1  2/13 (15.38%)  4
Social circumstances   
Social circumstances - Other (auto accident)  1  1/13 (7.69%)  1
Vascular disorders   
Hematoma  1  1/13 (7.69%)  1
Hypertension  1  12/13 (92.31%)  76
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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: Dr. Tito Fojo
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-2631
EMail: FojoT@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01255137    
Other Study ID Numbers: 100203
10-C-0203
First Submitted: December 4, 2010
First Posted: December 7, 2010
Results First Submitted: March 7, 2013
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013