Trial Outcomes & Findings for Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma (NCT NCT01558661)
NCT ID: NCT01558661
Last Updated: 2017-11-28
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
2 years
Results posted on
2017-11-28
Participant Flow
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
Participant milestones
| Measure |
AG-013736 (AXITINIB)
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 Study
STARTED
|
33
|
|
Overall Study
First Stage
|
18
|
|
Overall Study
Second Stage
|
15
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Baseline characteristics by cohort
| Measure |
AG-013736 (AXITINIB)
n=33 Participants
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).
|
|---|---|
|
Age, Continuous
|
56 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 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.
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
Outcome measures
| Measure |
AG-013736 (AXITINIB)
n=33 Participants
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 Response Rate
Complete Response
|
0 Participants
|
|
Overall Response Rate
Partial Response
|
3 Participants
|
|
Overall Response Rate
Stable Disease
|
25 Participants
|
|
Overall Response Rate
Progressive Disease
|
4 Participants
|
|
Overall Response Rate
Non-evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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"
Outcome measures
| Measure |
AG-013736 (AXITINIB)
n=32 Participants
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).
|
|---|---|
|
Median Progression-free Survival (PFS).
|
5.7 months
Interval 5.3 to 9.1
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
Outcome measures
| Measure |
AG-013736 (AXITINIB)
n=33 Participants
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).
|
|---|---|
|
MYB Immunohistochemistry (IHC)
MYB IHC Testing Not Done
|
7 Participants
|
|
MYB Immunohistochemistry (IHC)
MYB IHC Score 0
|
13 Participants
|
|
MYB Immunohistochemistry (IHC)
MYB IHC Score +1
|
8 Participants
|
|
MYB Immunohistochemistry (IHC)
MYB IHC Score +2
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
AG-013736 (AXITINIB)
n=33 Participants
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).
|
|---|---|
|
Number of Participants With Next Generation Sequencing (NGS)
No NGS sequencing
|
22 Participants
|
|
Number of Participants With Next Generation Sequencing (NGS)
NGS sequencing
|
11 Participants
|
Adverse Events
AG-013736 (AXITINIB)
Serious events: 10 serious events
Other events: 33 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
AG-013736 (AXITINIB)
n=33 participants at risk
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).
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Alkaline Phosphatase Increased
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Aspartate aminotransferase increased
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Blood bilirubin increased
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Psychiatric disorders
Confusion
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Eye disorders
Corneal Ulcer
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Death NOS
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Fatigue
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Fever
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Injury, poisoning and procedural complications
Fracture
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Vascular disorders
Hypertension
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Vascular disorders
Hypotension
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Infections and infestations
Infections and infestations - Other
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Nervous system disorders
Lethargy
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Infections and infestations
Lung infection
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Non-cardiac chest pain
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Nervous system disorders
Seizure
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Cardiac disorders
Sinus bradycardia
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Weight loss
|
3.0%
1/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
Other adverse events
| Measure |
AG-013736 (AXITINIB)
n=33 participants at risk
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).
|
|---|---|
|
Vascular disorders
Hypertension
|
97.0%
32/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Fatigue
|
90.9%
30/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Anorexia
|
54.5%
18/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Diarrhea
|
54.5%
18/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
54.5%
18/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Weight loss
|
54.5%
18/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
51.5%
17/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Nausea
|
48.5%
16/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Alanine aminotransferase increased
|
45.5%
15/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Alkaline phosphatase increased
|
42.4%
14/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Oral pain
|
42.4%
14/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
39.4%
13/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
12/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
11/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
9/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Platelet count decreased
|
27.3%
9/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
White blood cell decreased
|
27.3%
9/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.2%
8/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Dysphagia
|
24.2%
8/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Blood bilirubin increased
|
21.2%
7/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Constipation
|
21.2%
7/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
21.2%
7/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Endocrine disorders
Hypothyroidism
|
21.2%
7/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Hemoglobin increased
|
18.2%
6/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
18.2%
6/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
6/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Dyspepsia
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Nervous system disorders
Headache
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.2%
5/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
General disorders
Pain
|
12.1%
4/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
4/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Renal and urinary disorders
Proteinuria
|
12.1%
4/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
3/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
|
Investigations
Serum amylase increased
|
6.1%
2/33 • Up to 2 years
Toxicity will be graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 4.0).
|
Additional Information
Dr. Alan Ho, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place