Trial Outcomes & Findings for Sorafenib and Dacarbazine in Soft Tissue Sarcoma (NCT NCT00837148)

NCT ID: NCT00837148

Last Updated: 2015-11-20

Results Overview

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: at 18 weeks
• Results posted on: 2015-11-20

Participant Flow

Participant milestones

Measure	Soft Tissue Sarcoma Patients Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Overall Study STARTED	37
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Soft Tissue Sarcoma Patients Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Overall Study Adverse Event	1
Overall Study Death	1

Baseline Characteristics

Sorafenib and Dacarbazine in Soft Tissue Sarcoma

Baseline characteristics by cohort

Measure	Soft Tissue Sarcoma Patients n=37 Participants Sorafenib and Dacarbazine in Soft Tissue Sarcoma
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	10 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: at 18 weeks

Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

Outcome measures

Measure	Soft Tissue Sarcoma Patients n=35 Participants Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Overall Objective Response Partial Response (PR)	5 participants
Overall Objective Response Stable Disease (SD)	22 participants
Overall Objective Response Progression of Disease (POD)	8 participants

Adverse Events

Soft Tissue Sarcoma Patients

Serious events: 8 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Soft Tissue Sarcoma Patients n=37 participants at risk Sorafenib and Dacarbazine in Soft Tissue Sarcoma
General disorders Death not associated w CTCAE term- Death NOS	2.7% 1/37 • Number of events 1
General disorders Death not associated w CTCAE term-Disease progression NOS	2.7% 1/37 • Number of events 1
General disorders Fatigue (asthenia, lethargy, malaise)	2.7% 1/37 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	5.4% 2/37 • Number of events 3
Blood and lymphatic system disorders Hemorrhage/Bleeding, other	2.7% 1/37 • Number of events 2
Blood and lymphatic system disorders Leukocytes (total WBC)	5.4% 2/37 • Number of events 2
Respiratory, thoracic and mediastinal disorders Obstruction of airway-Bronchus	2.7% 1/37 • Number of events 1
General disorders Pain - Extremity-limb	2.7% 1/37 • Number of events 1
Blood and lymphatic system disorders Platelets	5.4% 2/37 • Number of events 3
Metabolism and nutrition disorders Sodium, low (hyponatremia)	2.7% 1/37 • Number of events 1
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	2.7% 1/37 • Number of events 1

Other adverse events

Measure	Soft Tissue Sarcoma Patients n=37 participants at risk Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Metabolism and nutrition disorders Albumin, low (hypoalbuminemia)	8.1% 3/37 • Number of events 3
Metabolism and nutrition disorders Amylase	8.1% 3/37 • Number of events 3
Metabolism and nutrition disorders Creatinine	8.1% 3/37 • Number of events 3
General disorders Fatigue (asthenia, lethargy, malaise)	8.1% 3/37 • Number of events 3
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	18.9% 7/37 • Number of events 7
Blood and lymphatic system disorders Hemoglobin	27.0% 10/37 • Number of events 10
Cardiac disorders Hypertension	5.4% 2/37 • Number of events 2
Blood and lymphatic system disorders Leukocytes (total WBC)	51.4% 19/37 • Number of events 19
Blood and lymphatic system disorders Lymphopenia	37.8% 14/37 • Number of events 14
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	54.1% 20/37 • Number of events 20
Metabolism and nutrition disorders Phosphate, low (hypophosphatemia)	40.5% 15/37 • Number of events 15
Blood and lymphatic system disorders Platelets	32.4% 12/37 • Number of events 12
Investigations Potassium, low (hypokalemia)	5.4% 2/37 • Number of events 2
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	18.9% 7/37 • Number of events 8
Metabolism and nutrition disorders Sodium, low (hyponatremia)	5.4% 2/37 • Number of events 2

Additional Information

Dr. William Tap

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4163

Email: tapw@mskcc.org

Results disclosure agreements

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