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Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

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ClinicalTrials.gov Identifier: NCT00495625
Recruitment Status : Terminated
First Posted : July 3, 2007
Results First Posted : March 23, 2012
Last Update Posted : March 27, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Cancer
Intervention Drug: Sunitinib Malate
Enrollment 33
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 33
Completed 23
Not Completed 10
Reason Not Completed
Did not complete at least 1 42 day cycle             10
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description 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 Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  63.6%
>=65 years
12
  36.4%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants
60.65
(24 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
7
  21.2%
Male
26
  78.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants
33
1.Primary Outcome
Title Number of Participants With Partial Response (PR) at Interim Analysis
Hide Description 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].
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
1
2.Primary Outcome
Title Number of Participants With Stable Disease (SD) at Interim Analysis
Hide Description 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].
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
6
3.Primary Outcome
Title Number of Participants With Progressive Disease (PD) at Interim Analysis
Hide Description 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].
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
8
4.Secondary Outcome
Title Participant Time to Tumor Progression (TTP)
Hide Description 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.
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
Not analyzed. The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Overall Survival (OS)
Hide Description Overall survival (OS) of sunitinib malate in the treatment in unresectable HCC
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had not expired on their off study date.
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
20
6.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description The toxicity of sunitinib malate in the treatment in unresectable HCC
Time Frame On Treatment to Off Study - average of 7 months per participant
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description:
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 Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
11
Time Frame 3 Years and 4 Months
Adverse Event Reporting Description First Treatment Start Date: 10/13/06 Last Off Study Date: 2/19/10
 
Arm/Group Title Sunitinib Malate (SUO11248) Treatment
Hide Arm/Group Description 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.
All-Cause Mortality
Sunitinib Malate (SUO11248) Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate (SUO11248) Treatment
Affected / at Risk (%) # Events
Total   11/33 (33.33%)    
Blood and lymphatic system disorders   
Hemoglobin  1 [1]  1/33 (3.03%)  1
Gastrointestinal disorders   
Ascites - Non-malignant  1 [1]  1/33 (3.03%)  1
Dehydration  1 [2]  1/33 (3.03%)  1
Diarrhea  1 [2]  1/33 (3.03%)  1
Nausea  1 [2]  1/33 (3.03%)  1
Vomiting  1 [2]  1/33 (3.03%)  1
General disorders   
Death - Disease Progression  1 [3]  4/33 (12.12%)  4
Sudden Death  1 [4]  1/33 (3.03%)  1
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound  1 [1]  1/33 (3.03%)  1
Metabolism and nutrition disorders   
Potassium, serum-low (hypokalemia)  1 [5]  1/33 (3.03%)  1
Sodium, serum -low (hyponatremia)  1 [5]  1/33 (3.03%)  1
Sodium, serum-low (hyponatremia)  1 [1]  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion (non-malignant)  1 [6]  1/33 (3.03%)  1
Vascular disorders   
Thrombosis/thrombus/embolism  1 [6]  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Grade 3 - Unrelated
[2]
Grade 3 - Probably related
[3]
Grade 5 - Death not associated with CTCAE term - Unrelated
[4]
Grade 5 - Death not associated with CTCAE term - unlikely that it is related
[5]
Grade 1 - Unrelated
[6]
Grade 2 - Unrelated
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib Malate (SUO11248) Treatment
Affected / at Risk (%) # Events
Total   31/33 (93.94%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC)  1  9/33 (27.27%)  18
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)  1  8/33 (24.24%)  15
Platelets  1  7/33 (21.21%)  14
Hemoglobin  1  4/33 (12.12%)  6
Blood/Bone Marrow - Other  1  2/33 (6.06%)  2
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic synd  1  10/33 (30.30%)  21
Coagulation - Other  1  1/33 (3.03%)  1
INR (International Normalized Ratio of prothrombin time)  1  1/33 (3.03%)  1
Edema: limb  1  6/33 (18.18%)  6
Edema: head and neck  1  1/33 (3.03%)  1
Edema: trunk/genital  1  1/33 (3.03%)  1
Cardiac disorders   
Hypertension  1  3/33 (9.09%)  3
Supraventricular and nodal arrhythmia - Sinus tachycardia  1  1/33 (3.03%)  1
Endocrine disorders   
Thyroid function, high (hyperthyroidism, thyrotoxicosis)  1  2/33 (6.06%)  2
Thyroid function, low (hypothyroidism)  1  1/33 (3.03%)  1
Eye disorders   
Watery eye (epiphora, tearing)  1  2/33 (6.06%)  2
Gastrointestinal disorders   
Diarrhea  1  15/33 (45.45%)  22
Nausea  1  15/33 (45.45%)  18
Anorexia  1  12/33 (36.36%)  13
Mucositis/stomatitis (clinical exam) - Oral cavity  1  9/33 (27.27%)  11
Taste alteration (dysgeusia)  1  8/33 (24.24%)  12
Vomiting  1  7/33 (21.21%)  8
Heartburn/dyspepsia  1  6/33 (18.18%)  6
Gastrointestinal - Other  1  5/33 (15.15%)  7
Dehydration  1  3/33 (9.09%)  3
Gastritis (including bile reflux gastritis)  1  3/33 (9.09%)  3
Ascites (non-malignant)  1  1/33 (3.03%)  1
Constipation  1  2/33 (6.06%)  2
Distension/bloating, abdominal  1  2/33 (6.06%)  2
Flatulence  1  2/33 (6.06%)  3
Dysphagia (difficulty swallowing)  1  1/33 (3.03%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  19/33 (57.58%)  22
Fever  1 [1]  3/33 (9.09%)  3
Insomnia  1  3/33 (9.09%)  3
Rigors/chills  1  2/33 (6.06%)  2
Weight loss  1  2/33 (6.06%)  2
Sweating (diaphoresis)  1  1/33 (3.03%)  2
Weight gain  1  1/33 (3.03%)  1
Constitutional symptoms - Other  1  4/33 (12.12%)  5
Pain - Abdomen NOS  1  7/33 (21.21%)  9
Pain - Head/headache  1  5/33 (15.15%)  7
Pain - Back  1  3/33 (9.09%)  3
Pain - Muscle  1  3/33 (9.09%)  3
Pain - Extremity-limb  1  2/33 (6.06%)  3
Pain - Bone  1  1/33 (3.03%)  1
Pain - Joint  1  1/33 (3.03%)  1
Pain - Oral-gums  1  1/33 (3.03%)  1
Paiin - Other  1  1/33 (3.03%)  1
Pain - Testicle  1  1/33 (3.03%)  1
Pain - Tumor  1  1/33 (3.03%)  3
Dizziness  1  1/33 (3.03%)  2
Extrapyramidal/involuntary movement/restlessness  1  1/33 (3.03%)  1
Memory impairment  1  1/33 (3.03%)  1
Neuropathy: motor  1  1/33 (3.03%)  1
Somnolence/depressed level of consciousness  1  1/33 (3.03%)  1
Syncope (fainting)  1  1/33 (3.03%)  1
Tremor  1  1/33 (3.03%)  1
Flu-like syndrome  1  1/33 (3.03%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/33 (3.03%)  2
Infections and infestations   
Febrile neutropenia  1 [2]  1/33 (3.03%)  1
Infection with noral ANCl or lGrade 1 or 2 neutrophils - Urinary tract NOS  1  1/33 (3.03%)  1
Metabolism and nutrition disorders   
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  8/33 (24.24%)  8
Bilirubin (hyperbilirubinemia)  1  4/33 (12.12%)  5
ALT, SGPT(serum glutamic pyruvic transaminase)  1  3/33 (9.09%)  5
Potassium, serum-low (hypokalemia)  1  2/33 (6.06%)  2
Alkaline phosphatase  1  2/33 (6.06%)  2
Glucose, serum-low (hypoglycemia)  1  1/33 (3.03%)  1
Potassium, serum-high (hyperkalemia)  1  1/33 (3.03%)  1
Musculoskeletal and connective tissue disorders   
Arthritis (non-septic)  1  1/33 (3.03%)  1
Muscle weakness  1 [3]  1/33 (3.03%)  1
Muscle weakness  1 [4]  1/33 (3.03%)  1
Musculoskeletal/Soft Tissue - Other  1  1/33 (3.03%)  1
Psychiatric disorders   
Mental status  1  2/33 (6.06%)  2
Mood alteration - Depression  1  2/33 (6.06%)  2
Cognitive disturbance  1  1/33 (3.03%)  1
Mood alteration - Anxiety  1  1/33 (3.03%)  1
Renal and urinary disorders   
Renal/Genitourinary - Other  1  2/33 (6.06%)  2
Incontinence, urinary  1  1/33 (3.03%)  1
Urinary retention (including neurogenic bladder)  1  1/33 (3.03%)  1
Urine color change  1  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  7/33 (21.21%)  7
Cough  1  2/33 (6.06%)  2
Hemorrhage, pulmonary/upper respiratory - Nose  1  1/33 (3.03%)  2
Skin and subcutaneous tissue disorders   
Hyperpigmentation  1  7/33 (21.21%)  9
Rash: hand-foot skin reaction  1  6/33 (18.18%)  11
Dermatology/Skin - Other  1  5/33 (15.15%)  6
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  3/33 (9.09%)  3
Rash/desquamation  1  2/33 (6.06%)  5
Dry skin  1  1/33 (3.03%)  1
Pruritus/itching  1  1/33 (3.03%)  1
Rash: acne/acneiform  1  1/33 (3.03%)  1
Vascular disorders   
Phlebitis (including superficial thrombosis)  1  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
[1]
Fever (in the absence of neutropenia, where neutropenia is defined as ANC<1.0 x 10^9/L)
[2]
Fever of unknown origin without clinically or microbiologically documented infection ANC<1.0 x 10^9/L, fever >=38.5 degrees C
[3]
Generalized or specific area (not due to neuropathy) - Extremity - lower
[4]
Generalized or specific area (not due to neuropathy) - Whole body/generalized
The Principal Investigator who initiated the study left Moffitt before reaching the target enrollment required to perform the planned analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jonathan Strosberg, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7257
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00495625     History of Changes
Other Study ID Numbers: MCC-14733
Pfizer #2005-0880 ( Other Identifier: Pfizer )
First Submitted: June 29, 2007
First Posted: July 3, 2007
Results First Submitted: January 12, 2012
Results First Posted: March 23, 2012
Last Update Posted: March 27, 2012