Trial Outcomes & Findings for Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer (NCT NCT00134043)

Last Updated: 2014-08-11

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2014-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	DTCs (Well-differentiated Thyroid Carcinomas) Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally	MTC (Medullary Thyroid Cancer) Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally
Overall Study STARTED	16	3
Overall Study COMPLETED	16	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Suberoylanilide Hydroxamic Acid in Treating Patients With Metastatic and/or Locally Advanced or Locally Recurrent Thyroid Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTCs (Well-differentiated Thyroid Carcinomas) n=16 Participants Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally	MTC (Medullary Thyroid Cancer) n=3 Participants Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally	Total n=19 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	65 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	1 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	3 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	3 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 0 (Fully active)	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
ECOG (Eastern Cooperative Oncology Group) performance status 1(restricted in physically strenuous activity)	10 participants n=5 Participants	1 participants n=7 Participants	11 participants n=5 Participants
Site of metastasis Lungs	16 participants n=5 Participants	0 participants n=7 Participants	16 participants n=5 Participants
Site of metastasis Lymph nodes	8 participants n=5 Participants	1 participants n=7 Participants	9 participants n=5 Participants
Site of metastasis Bones	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Site of metastasis Brain	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Site of metastasis 1-2 sites	13 participants n=5 Participants	1 participants n=7 Participants	14 participants n=5 Participants
Site of metastasis More than 2 sites	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Previous therapies Surgery	15 number of n=5 Participants	3 number of n=7 Participants	18 number of n=5 Participants
Previous therapies Iodin-131	16 number of n=5 Participants	0 number of n=7 Participants	16 number of n=5 Participants
Previous therapies External beam radiation	6 number of n=5 Participants	2 number of n=7 Participants	8 number of n=5 Participants
Previous therapies Cytotoxic chemotherapy	6 number of n=5 Participants	2 number of n=7 Participants	8 number of n=5 Participants
Pathology of thyroid carcinoma Classic PTC	12 participants n=5 Participants	0 participants n=7 Participants	12 participants n=5 Participants
Pathology of thyroid carcinoma Follicular variant of PTC	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Pathology of thyroid carcinoma FTC	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Pathology of thyroid carcinoma Hurthle cell	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Pathology of thyroid carcinoma MTC	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Per RECIST (Response Evaluation Criteria in Solid Tumors)

Outcome measures

Outcome measures
Measure	DTCs (Well-differentiated Thyroid Carcinomas) n=16 Participants Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.	MTC (Medullary Thyroid Cancer) n=5 Participants Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally
Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria PR (Partial Response)	0 percentage of participants	0 percentage of participants
Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria CR (Complete Response)	0 percentage of participants	0 percentage of participants
Objective Response Rate (PR + CR) Using RECIST/WHO Response Criteria Stable disease	56 percentage of participants	0 percentage of participants

Adverse Events

Arm I & Arm II

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I & Arm II n=19 participants at risk Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks. vorinostat: Given orally
Gastrointestinal disorders Abdominal Cramping	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Skin and subcutaneous tissue disorders Alopecia	42.1% 8/19 • Number of events 8 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Metabolism and nutrition disorders Anorexia	84.2% 16/19 • Number of events 16 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Psychiatric disorders Anxiety	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Arterial thrombus	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Ataxia	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Eye disorders Blurry vision	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Respiratory, thoracic and mediastinal disorders Bronchitis/pneumonia	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Bruising/hematoma	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
General disorders Chest pain (muscle)	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
General disorders Chills/Sweating	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Psychiatric disorders Confusion	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Respiratory, thoracic and mediastinal disorders Cough	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Deep vein thrombosis	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Metabolism and nutrition disorders Dehydration	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Diarrhea	68.4% 13/19 • Number of events 13 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Dizziness	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Dry Mouth	26.3% 5/19 • Number of events 5 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Respiratory, thoracic and mediastinal disorders Dsypnea	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
General disorders Fatigue	78.9% 15/19 • Number of events 15 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Flatulence/Bloating	31.6% 6/19 • Number of events 6 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Flushing	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Musculoskeletal and connective tissue disorders General Weakness	36.8% 7/19 • Number of events 7 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders General pain	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Headache	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Heartburn	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations Herpes zoster	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Hypertension	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Memory loss	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Vascular disorders Minor bleeding	26.3% 5/19 • Number of events 5 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Mouth sores	21.1% 4/19 • Number of events 4 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Musculoskeletal and connective tissue disorders Muscle cramps	26.3% 5/19 • Number of events 5 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Skin and subcutaneous tissue disorders Nail changes	15.8% 3/19 • Number of events 3 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Nausea/Vomiting	68.4% 13/19 • Number of events 13 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Paresthesias	5.3% 1/19 • Number of events 1 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Skin and subcutaneous tissue disorders Rash	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Gastrointestinal disorders Taste changes	47.4% 9/19 • Number of events 9 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Nervous system disorders Tremor	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations Weight loss	68.4% 13/19 • Number of events 13 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Blood and lymphatic system disorders Anemia	78.9% 15/19 • Number of events 15 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Blood and lymphatic system disorders Leukopenia	63.2% 12/19 • Number of events 12 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations Neutropenia	36.8% 7/19 • Number of events 7 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations Lymphopenia	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Injury, poisoning and procedural complications Thrombocytopenia	73.7% 14/19 • Number of events 14 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations High PTT	10.5% 2/19 • Number of events 2 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Investigations High P/INR	21.1% 4/19 • Number of events 4 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0
Metabolism and nutrition disorders Hyperglycemia	52.6% 10/19 • Number of events 10 • NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting. AEs were worst grade experienced by patient on study and were primarily grade 1-3 according to the NCI Common Terminology Criteria for Adverse Events version 3.0

Additional Information

Manisha Shah, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-8629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60