Trial Outcomes & Findings for Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC) (NCT NCT00495625)
NCT ID: NCT00495625
Last Updated: 2012-03-27
Results Overview
Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
On Treatment to Off Study - average of 7 months per participant
Results posted on
2012-03-27
Participant Flow
All patients with unresectable or metastatic hepatocellular cancer (HCC) seen at the Moffitt Cancer Center Gastrointestinal (GI) Clinic were screened for eligibility to be enrolled in the study.
Participant milestones
| Measure |
Sunitinib Malate (SUO11248) Treatment
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Sunitinib Malate (SUO11248) Treatment
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Overall Study
Did not complete at least 1 42 day cycle
|
10
|
Baseline Characteristics
Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)
Baseline characteristics by cohort
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=33 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age Continuous
|
60.65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: 17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.
Partial Response at Interim Analysis. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (unidimensional measurement) of target lesions, taking as reference the baseline sum longest diameter (LD). Response was evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].
Outcome measures
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=17 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Number of Participants With Partial Response (PR) at Interim Analysis
|
1 participants
|
PRIMARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: 17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.
Stable Disease (SD) Rate at Interim Analysis. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].
Outcome measures
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=17 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Number of Participants With Stable Disease (SD) at Interim Analysis
|
6 participants
|
PRIMARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: 17 of the 23 patients that were enrolled at time of Interim Analysis (patients enrolled between 10/13/06 and 9/24/07) were evaluable for response.
Progressive Disease Rate. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Response and progression were evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\].
Outcome measures
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=17 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Number of Participants With Progressive Disease (PD) at Interim Analysis
|
8 participants
|
SECONDARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.
Investigators planned to determine the time to tumor progression (TTP) of sunitinib malate in the treatment in unresectable Hepatocellular Cancers (HCC). TTP is defined as the duration of time from start of treatment to time of progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: Participants who had not expired on their off study date.
Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC
Outcome measures
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=33 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Number of Participants With Overall Survival (OS)
|
20 participants
|
SECONDARY outcome
Timeframe: On Treatment to Off Study - average of 7 months per participantPopulation: All participants
The toxicity of sunitinib malate in the treatment in unresectable HCC
Outcome measures
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=33 Participants
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
11 participants
|
Adverse Events
Sunitinib Malate (SUO11248) Treatment
Serious events: 11 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=33 participants at risk
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Death - Disease Progression
|
12.1%
4/33 • Number of events 4 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Sudden Death
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Ascites - Non-malignant
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Nausea
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Sodium, serum -low (hyponatremia)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
Other adverse events
| Measure |
Sunitinib Malate (SUO11248) Treatment
n=33 participants at risk
Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
45.5%
15/33 • Number of events 22 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Nausea
|
45.5%
15/33 • Number of events 18 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Anorexia
|
36.4%
12/33 • Number of events 13 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
27.3%
9/33 • Number of events 11 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
24.2%
8/33 • Number of events 12 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
7/33 • Number of events 8 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
18.2%
6/33 • Number of events 6 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
15.2%
5/33 • Number of events 7 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Dehydration
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
57.6%
19/33 • Number of events 22 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Fever
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Insomnia
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Rigors/chills
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Weight loss
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Sweating (diaphoresis)
|
3.0%
1/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Weight gain
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
27.3%
9/33 • Number of events 18 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
24.2%
8/33 • Number of events 15 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Platelets
|
21.2%
7/33 • Number of events 14 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Hemoglobin
|
12.1%
4/33 • Number of events 6 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
21.2%
7/33 • Number of events 9 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
18.2%
6/33 • Number of events 11 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
15.2%
5/33 • Number of events 6 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.1%
2/33 • Number of events 5 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Constitutional symptoms - Other
|
12.1%
4/33 • Number of events 5 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Abdomen NOS
|
21.2%
7/33 • Number of events 9 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Head/headache
|
15.2%
5/33 • Number of events 7 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Back
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Muscle
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Extremity-limb
|
6.1%
2/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Bone
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Joint
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Oral-gums
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Paiin - Other
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Testicle
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Pain - Tumor
|
3.0%
1/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic synd
|
30.3%
10/33 • Number of events 21 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Coagulation - Other
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
24.2%
8/33 • Number of events 8 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
12.1%
4/33 • Number of events 5 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
ALT, SGPT(serum glutamic pyruvic transaminase)
|
9.1%
3/33 • Number of events 5 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Psychiatric disorders
Mental status
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Psychiatric disorders
Mood alteration - Depression
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Psychiatric disorders
Cognitive disturbance
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Dizziness
|
3.0%
1/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Extrapyramidal/involuntary movement/restlessness
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Memory impairment
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Psychiatric disorders
Mood alteration - Anxiety
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Neuropathy: motor
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Somnolence/depressed level of consciousness
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Syncope (fainting)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Tremor
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.2%
7/33 • Number of events 7 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Edema: limb
|
18.2%
6/33 • Number of events 6 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Blood and lymphatic system disorders
Edema: trunk/genital
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Renal and urinary disorders
Incontinence, urinary
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Renal and urinary disorders
Urine color change
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Cardiac disorders
Hypertension
|
9.1%
3/33 • Number of events 3 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis)
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Infections and infestations
Febrile neutropenia
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Infections and infestations
Infection with noral ANCl or lGrade 1 or 2 neutrophils - Urinary tract NOS
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Eye disorders
Watery eye (epiphora, tearing)
|
6.1%
2/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Vascular disorders
Phlebitis (including superficial thrombosis)
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Sinus tachycardia
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
3.0%
1/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
Hepatobiliary disorders
Cholecystitis
|
3.0%
1/33 • Number of events 2 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
|
General disorders
Flu-like syndrome
|
3.0%
1/33 • Number of events 1 • 3 Years and 4 Months
First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
|
Additional Information
Jonathan Strosberg, M.D.
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place