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Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00400569
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : August 28, 2012
Last Update Posted : August 28, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liposarcoma
Leiomyosarcoma
Fibrosarcoma
Malignant Fibrous Histiocytoma
Intervention Drug: Sunitinib Malate (SU011248)
Enrollment 48
Recruitment Details From September 2006 to August 2007, a total of 48 patients were enrolled on the study by the Moffitt Cancer Center Sarcoma Program. In general, the patients had been heavily pretreated previously, with a significant number receiving more than one prior chemotherapy regimen and most with multiple metastatic sites.
Pre-assignment Details  
Arm/Group Title Experimental: Sunitinib Malate (SU011248) Treatment
Hide Arm/Group Description Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Period Title: Overall Study
Started 48
Completed 47
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Experimental: Sunitinib Malate (SU011248) Treatment
Hide Arm/Group Description Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  56.3%
>=65 years
21
  43.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
29
  60.4%
Male
19
  39.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants
48
1.Primary Outcome
Title Number of Participants With Overall Response (OR)
Hide Description Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame From On Treatment to Off Study - average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants assessable for response
Arm/Group Title Experimental: Sunitinib Malate (SU011248) Treatment
Hide Arm/Group Description:
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Participants' Progression Free Survival (PFS)
Hide Description Time to tumor progression defined as the duration of time from start of treatment to time of progression. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame From On Treatment to Off Study - average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
Arm/Group Title Liposarcoma Cohort Only Leiomyosarcoma Cohort Only Malignant Fibrous Histiocytoma (MFH) Cohort Only
Hide Arm/Group Description:
Experimental: Sunitinib Malate (SU011248) Treatment
Experimental: Sunitinib Malate (SU011248) Treatment
Experimental: Sunitinib Malate (SU011248) Treatment
Overall Number of Participants Analyzed 18 15 14
Median (95% Confidence Interval)
Unit of Measure: months
3.9
(2.8 to 4.4)
4.2
(2.0 to 8.3)
2.5
(1.4 to 5.5)
3.Secondary Outcome
Title Participants' Overall Survival (OS)
Hide Description The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Time Frame From On Treatment to Off Study - average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study
Arm/Group Title Liposarcoma Cohort Only Leiomyosarcoma Cohort Only Malignant Fibrous Histiocytoma (MFH) Cohort Only
Hide Arm/Group Description:
Experimental: Sunitinib Malate (SU011248) Treatment
Experimental: Sunitinib Malate (SU011248) Treatment
Experimental: Sunitinib Malate (SU011248) Treatment
Overall Number of Participants Analyzed 18 15 14
Median (95% Confidence Interval)
Unit of Measure: months
18.6
(5.2 to 27.7)
10.1
(4.1 to 11.9)
13.6
(3.1 to 36.5)
4.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs)
Hide Description Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Time Frame 4 years, 7 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants
Arm/Group Title Experimental: Sunitinib Malate (SU011248) Treatment
Hide Arm/Group Description:
Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: participants
13
Time Frame 4 years, 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental: Sunitinib Malate (SU011248) Treatment
Hide Arm/Group Description Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
All-Cause Mortality
Experimental: Sunitinib Malate (SU011248) Treatment
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Experimental: Sunitinib Malate (SU011248) Treatment
Affected / at Risk (%) # Events
Total   13/48 (27.08%)    
Cardiac disorders   
Cardiac general  1  2/48 (4.17%)  2
Left ventricular systolic dysfunction  1  1/48 (2.08%)  1
General disorders   
Pain - Abdomen  1  3/48 (6.25%)  4
Death not associated with CTCAE term - Disease progression  1  3/48 (6.25%)  3
Hemorrhate/Bleeding  1  2/48 (4.17%)  2
Hepatobiliary disorders   
Liver dysfunction/failure  1  1/48 (2.08%)  1
Infections and infestations   
Infection with unknown ANC - Peritoneal cavity  1  1/48 (2.08%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/48 (2.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: Sunitinib Malate (SU011248) Treatment
Affected / at Risk (%) # Events
Total   39/48 (81.25%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1  20/48 (41.67%)  27
Neutropenia  1  14/48 (29.17%)  30
Cardiac disorders   
Hypertension  1  9/48 (18.75%)  9
Gastrointestinal disorders   
Diarrhea  1  22/48 (45.83%)  28
Mucositis  1  18/48 (37.50%)  22
Vomiting  1  16/48 (33.33%)  18
Dysguesia  1  18/48 (37.50%)  24
Dyspepsia  1  21/48 (43.75%)  22
General disorders   
Fatigue  1  30/48 (62.50%)  44
Hemorrhage/bleeding  1  4/48 (8.33%)  5
Metabolism and nutrition disorders   
Anorexia  1  10/48 (20.83%)  11
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  7/48 (14.58%)  8
Skin and subcutaneous tissue disorders   
Rash  1  15/48 (31.25%)  27
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
The trial was amended to exclude fibrosarcoma after only one patient was accrued while the other cohorts had completed 75% or more of their planned accrual. Only patients with liposarcoma, leiomyosarcoma, or MFH were enrolled after this amendment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alberto Chiappori, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-2158
EMail: alberto.chiappori@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00400569    
Other Study ID Numbers: MCC-14902
GA618075 ( Other Identifier: Pfizer Pharamaceutic )
First Submitted: November 15, 2006
First Posted: November 17, 2006
Results First Submitted: July 25, 2012
Results First Posted: August 28, 2012
Last Update Posted: August 28, 2012