Trial Outcomes & Findings for Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma (NCT NCT03370718)
NCT ID: NCT03370718
Last Updated: 2024-12-10
Results Overview
PFS rates will be monitored simultaneously using the Bayesian approach of Thall, Simon, Esty as extended by Thall and Sung. PFS is defined as no disease progression or death within the first 4 months of the proposed treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
At 4 months
Results posted on
2024-12-10
Participant Flow
The study assessed 28 patients for eligibility, 18 started treatment, and at present none remained on therapy.
Participant milestones
| Measure |
Cabozantinib
Patients with advanced adrenocortical carcinoma meeting inclusion and exclusion criteria
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cabozantinib
Patients with advanced adrenocortical carcinoma meeting inclusion and exclusion criteria
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma
Baseline characteristics by cohort
| Measure |
Cabozantinib
n=18 Participants
Patients with advanced adrenocortical carcinoma meeting inclusion and exclusion criteria
|
|---|---|
|
Age, Continuous
|
55.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 monthsPFS rates will be monitored simultaneously using the Bayesian approach of Thall, Simon, Esty as extended by Thall and Sung. PFS is defined as no disease progression or death within the first 4 months of the proposed treatment.
Outcome measures
| Measure |
Cabozantinib
n=18 Participants
Patients with advanced adrenocortical carcinoma meeting inclusion and exclusion criteria
|
|---|---|
|
Progression-free Survival (PFS) as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
|
72.2 precentage of participants
Interval 46.5 to 90.3
|
Adverse Events
Cabozantinib
Serious events: 0 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cabozantinib
n=18 participants at risk
Patients with advanced adrenocortical carcinoma meeting inclusion and exclusion criteria
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Alanine aminotransferase increased
|
77.8%
14/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Alkaline phosphatase increased
|
61.1%
11/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Anemia
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Aspartate aminotransferase increased
|
72.2%
13/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Belching
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Blood bilirubin increased
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Hepatobiliary disorders
Cholecystitis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Cortisol increase
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Creatinine increased
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Decreased Chloride
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
77.8%
14/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Dysgeusia
|
44.4%
8/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Edema
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Erythema/Rash
|
27.8%
5/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Facial pain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Fatigue
|
55.6%
10/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Free T4 alteration
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Gait disturbance
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
GGT increased
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Infections and infestations
Gingival pain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Hair color changing
|
22.2%
4/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Hair loss
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Hand pain/ joint stiffness
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Headache
|
27.8%
5/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Heat intolerance
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Hematemesis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Hydronephrosis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Vascular disorders
Hypertension
|
66.7%
12/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.8%
5/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.8%
5/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
50.0%
9/18 • Through study completion, an average of 3 years and 3 months
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased amylase
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased BUN
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Increased calluses on feet
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased GGT
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased Globulin
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Increased LDH
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Increased PT
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased PTT
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased skin sensitivity
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Endocrine disorders
Increased T4
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Increased Total Protein
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Endocrine disorders
Increased TSH
|
44.4%
8/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
INR increased
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Psychiatric disorders
Insomnia
|
22.2%
4/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Itching
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Lightheadedness
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Lipase increased
|
44.4%
8/18 • Through study completion, an average of 3 years and 3 months
|
|
Eye disorders
Loss of Peripheral vision
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma In Situ
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
22.2%
4/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
General disorders
Nasal discharge
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Nausea
|
50.0%
9/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Odynophagia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Oral hemorrhage
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Pallor
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
44.4%
8/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Pancreatitis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Paresthesia
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Peeling and Dry blistering
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Platelet count decreased
|
38.9%
7/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bibasilar
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
9/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Radiculitis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Renal Insufficiency
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Cardiac disorders
Sinus tachycardia
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
27.8%
5/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Skin and subcutaneous tissue disorders
Slow growth of hair
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Musculoskeletal and connective tissue disorders
Soreness on sole of feet
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Vascular disorders
Thromboembolic event
|
16.7%
3/18 • Through study completion, an average of 3 years and 3 months
|
|
Endocrine disorders
Thyrotoxicosis
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Blood and lymphatic system disorders
Total Protein decreased
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Ureteral obstruction
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Urinary hesitancy
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Renal and urinary disorders
Urinary tract pain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Nervous system disorders
Voice change
|
11.1%
2/18 • Through study completion, an average of 3 years and 3 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
6/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Weight gain
|
5.6%
1/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
Weight loss
|
66.7%
12/18 • Through study completion, an average of 3 years and 3 months
|
|
Investigations
White blood cell decreased
|
72.2%
13/18 • Through study completion, an average of 3 years and 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place