Trial Outcomes & Findings for Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma (NCT NCT00400569)

NCT ID: NCT00400569

Last Updated: 2012-08-28

Results Overview

Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: From On Treatment to Off Study - average of 6 months
• Results posted on: 2012-08-28

Participant Flow

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.

Participant milestones

Measure	Experimental: Sunitinib Malate (SU011248) Treatment Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Study STARTED	48
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Experimental: Sunitinib Malate (SU011248) Treatment Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Overall Study Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=48 Participants Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants

PRIMARY outcome

Timeframe: From On Treatment to Off Study - average of 6 months

Population: All participants assessable for response

Objective Radiographic Response Rate. Response assessments were based on the longest diameter tumor measurements in accordance with Response Evaluation Criteria in Solid Tumors (RECIST).

Outcome measures

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=43 Participants Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks	Leiomyosarcoma Cohort Only Experimental: Sunitinib Malate (SU011248) Treatment	Malignant Fibrous Histiocytoma (MFH) Cohort Only Experimental: Sunitinib Malate (SU011248) Treatment
Number of Participants With Overall Response (OR)	1 participants	—	—

SECONDARY outcome

Timeframe: From On Treatment to Off Study - average of 6 months

Population: All participants who completed the study

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).

Outcome measures

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=18 Participants Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks	Leiomyosarcoma Cohort Only n=15 Participants Experimental: Sunitinib Malate (SU011248) Treatment	Malignant Fibrous Histiocytoma (MFH) Cohort Only n=14 Participants Experimental: Sunitinib Malate (SU011248) Treatment
Participants' Progression Free Survival (PFS)	3.9 months Interval 2.8 to 4.4	4.2 months Interval 2.0 to 8.3	2.5 months Interval 1.4 to 5.5

SECONDARY outcome

Timeframe: From On Treatment to Off Study - average of 6 months

Population: All participants who completed the study

The median OS times (months) for liposarcoma, leiomyosarcoma and MFH.

Outcome measures

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=18 Participants Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks	Leiomyosarcoma Cohort Only n=15 Participants Experimental: Sunitinib Malate (SU011248) Treatment	Malignant Fibrous Histiocytoma (MFH) Cohort Only n=14 Participants Experimental: Sunitinib Malate (SU011248) Treatment
Participants' Overall Survival (OS)	18.6 months Interval 5.2 to 27.7	10.1 months Interval 4.1 to 11.9	13.6 months Interval 3.1 to 36.5

SECONDARY outcome

Timeframe: 4 years, 7 months

Population: All Participants

Determine the number of participants who experience Serious Adverse events while on sunitinib malate study.

Outcome measures

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=48 Participants Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks	Leiomyosarcoma Cohort Only Experimental: Sunitinib Malate (SU011248) Treatment	Malignant Fibrous Histiocytoma (MFH) Cohort Only Experimental: Sunitinib Malate (SU011248) Treatment
Number of Participants With Serious Adverse Events (SAEs)	13 participants	—	—

Adverse Events

Experimental: Sunitinib Malate (SU011248) Treatment

Serious events: 13 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=48 participants at risk Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Hepatobiliary disorders Liver dysfunction/failure	2.1% 1/48 • Number of events 1 • 4 years, 7 months
General disorders Pain - Abdomen	6.2% 3/48 • Number of events 4 • 4 years, 7 months
General disorders Death not associated with CTCAE term - Disease progression	6.2% 3/48 • Number of events 3 • 4 years, 7 months
Infections and infestations Infection with unknown ANC - Peritoneal cavity	2.1% 1/48 • Number of events 1 • 4 years, 7 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 1/48 • Number of events 1 • 4 years, 7 months
Cardiac disorders Cardiac general	4.2% 2/48 • Number of events 2 • 4 years, 7 months
General disorders Hemorrhate/Bleeding	4.2% 2/48 • Number of events 2 • 4 years, 7 months
Cardiac disorders Left ventricular systolic dysfunction	2.1% 1/48 • Number of events 1 • 4 years, 7 months

Other adverse events

Measure	Experimental: Sunitinib Malate (SU011248) Treatment n=48 participants at risk Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
Metabolism and nutrition disorders Anorexia	20.8% 10/48 • Number of events 11 • 4 years, 7 months
General disorders Fatigue	62.5% 30/48 • Number of events 44 • 4 years, 7 months
Gastrointestinal disorders Diarrhea	45.8% 22/48 • Number of events 28 • 4 years, 7 months
Gastrointestinal disorders Mucositis	37.5% 18/48 • Number of events 22 • 4 years, 7 months
Gastrointestinal disorders Vomiting	33.3% 16/48 • Number of events 18 • 4 years, 7 months
Gastrointestinal disorders Dysguesia	37.5% 18/48 • Number of events 24 • 4 years, 7 months
Gastrointestinal disorders Dyspepsia	43.8% 21/48 • Number of events 22 • 4 years, 7 months
Blood and lymphatic system disorders Thrombocytopenia	41.7% 20/48 • Number of events 27 • 4 years, 7 months
Blood and lymphatic system disorders Neutropenia	29.2% 14/48 • Number of events 30 • 4 years, 7 months
Cardiac disorders Hypertension	18.8% 9/48 • Number of events 9 • 4 years, 7 months
Respiratory, thoracic and mediastinal disorders Dyspnea	14.6% 7/48 • Number of events 8 • 4 years, 7 months
General disorders Hemorrhage/bleeding	8.3% 4/48 • Number of events 5 • 4 years, 7 months
Skin and subcutaneous tissue disorders Rash	31.2% 15/48 • Number of events 27 • 4 years, 7 months

Additional Information

Alberto Chiappori, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-2158

Email: alberto.chiappori@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place