Trial Outcomes & Findings for Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer (NCT NCT01255137)
NCT ID: NCT01255137
Last Updated: 2013-06-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 years
Results posted on
2013-06-27
Participant Flow
Participant milestones
| Measure |
Adrenal Cortex Neoplasms
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 Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Axitinib (AG-013736) With Evaluation of the VEGF-Pathway in Metastatic, Recurrent or Primary Unresectable Adrenocortical Cancer
Baseline characteristics by cohort
| Measure |
Adrenal Cortex Neoplasms
n=13 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age Continuous
|
53.89 years
STANDARD_DEVIATION 11.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsResponse 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.
Outcome measures
| Measure |
Adrenal Cortex Neoplasms
n=13 Participants
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
|
|---|---|
|
Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)
Complete Response
|
0 Participants
|
|
Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)
Partial Response
|
0 Participants
|
|
Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)
Progression
|
13 Participants
|
|
Response Rate (RR) of Axitinib Administered Daily, in Patients With Recurrent, Metastatic, or Primary Unresectable Adrenocortical Cancer (ACC)
Stable Disease
|
0 Participants
|
SECONDARY outcome
Timeframe: 3/2/11 - 8/2/12Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse events module.
Outcome measures
| Measure |
Adrenal Cortex Neoplasms
n=13 Participants
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
|
|---|---|
|
Number of Participants With Adverse Events
|
13 Participants
|
Adverse Events
Adrenal Cortex Neoplasms
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adrenal Cortex Neoplasms
n=13 participants at risk
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
|
|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Adrenal Cortex Neoplasms
n=13 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
46.2%
6/13 • Number of events 10
|
|
Investigations
Activated partial thromboplastin time prolonged
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
30.8%
4/13 • Number of events 5
|
|
Investigations
Alkaline phosphatase increased
|
38.5%
5/13 • Number of events 8
|
|
Gastrointestinal disorders
Anal hemorrhage
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
61.5%
8/13 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
4/13 • Number of events 10
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.5%
5/13 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
38.5%
5/13 • Number of events 10
|
|
Immune system disorders
Autoimmune disorder
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
15.4%
2/13 • Number of events 2
|
|
Eye disorders
Blurred vision
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
7.7%
1/13 • Number of events 1
|
|
Investigations
CPK increased
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
23.1%
3/13 • Number of events 4
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
38.5%
5/13 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Creatinine increased
|
30.8%
4/13 • Number of events 7
|
|
Endocrine disorders
Cushingoid
|
7.7%
1/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 9
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
23.1%
3/13 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Edema face
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 13
|
|
General disorders
Fever
|
15.4%
2/13 • Number of events 2
|
|
General disorders
Gait disturbance
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • Number of events 3
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hematoma
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
7.7%
1/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
30.8%
4/13 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
23.1%
3/13 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
53.8%
7/13 • Number of events 7
|
|
Vascular disorders
Hypertension
|
92.3%
12/13 • Number of events 76
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
53.8%
7/13 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
15.4%
2/13 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.1%
3/13 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
46.2%
6/13 • Number of events 6
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1
|
|
Investigations
Lipase increased
|
15.4%
2/13 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
46.2%
6/13 • Number of events 10
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Oral dysesthesia
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
15.4%
2/13 • Number of events 5
|
|
Gastrointestinal disorders
Pancreatitis
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.4%
2/13 • Number of events 2
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.4%
2/13 • Number of events 4
|
|
Cardiac disorders
Sinus bradycardia
|
7.7%
1/13 • Number of events 1
|
|
Social circumstances
Social circumstances - Other (auto accident)
|
7.7%
1/13 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
7.7%
1/13 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
15.4%
2/13 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency
|
15.4%
2/13 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract pain
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
Urinary urgency
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
7.7%
1/13 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
23.1%
3/13 • Number of events 3
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 3
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Number of events 1
|
Additional Information
Dr. Tito Fojo
National Cancer Institute, National Institutes of Health
Phone: 301-496-2631
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place