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

• 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: H. Lee Moffitt Cancer Center and Research Institute
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Experimental: Sunitinib Malate (SU011248) Treatment
Arm/Group Description		Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Number of Baseline Participants		48
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

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Overall Response (OR)
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

Outcome Measure Data

Analysis Population Description

All participants assessable for response

Arm/Group Title	Experimental: Sunitinib Malate (SU011248) Treatment
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)
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

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Liposarcoma Cohort Only	Leiomyosarcoma Cohort Only	Malignant Fibrous Histiocytoma (MFH) Cohort Only
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)
Description	The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.
Time Frame	From On Treatment to Off Study - average of 6 months

Outcome Measure Data

Analysis Population Description

All participants who completed the study

Arm/Group Title	Liposarcoma Cohort Only	Leiomyosarcoma Cohort Only	Malignant Fibrous Histiocytoma (MFH) Cohort Only
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)
Description	Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.
Time Frame	4 years, 7 months

Outcome Measure Data

Analysis Population Description

All Participants

Arm/Group Title	Experimental: Sunitinib Malate (SU011248) Treatment
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

Adverse Events

Time Frame	4 years, 7 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Experimental: Sunitinib Malate (SU011248) Treatment
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	--/--
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
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

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Alberto Chiappori, M.D.
• Organization: H. Lee Moffitt Cancer Center and Research Institute
• Phone: 813-745-2158
• EMail: alberto.chiappori@moffitt.org

• 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