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Trial record 25 of 99 for:    "Sarcoma, Synovial"

Sorafenib and Dacarbazine in Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00837148
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sarcoma
Synovial Sarcoma
Leiomyosarcoma
Malignant Peripheral Nerve Sheath Tumor
Intervention Drug: Sorafenib and Dacarbazine
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Soft Tissue Sarcoma Patients
Hide Arm/Group Description Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Period Title: Overall Study
Started 37
Completed 35
Not Completed 2
Reason Not Completed
Adverse Event             1
Death             1
Arm/Group Title Soft Tissue Sarcoma Patients
Hide Arm/Group Description Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  73.0%
>=65 years
10
  27.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
19
  51.4%
Male
18
  48.6%
1.Primary Outcome
Title Overall Objective Response
Hide Description 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)
Time Frame at 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Soft Tissue Sarcoma Patients
Hide Arm/Group Description:
Sorafenib and Dacarbazine in Soft Tissue Sarcoma
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 5
Stable Disease (SD) 22
Progression of Disease (POD) 8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Soft Tissue Sarcoma Patients
Hide Arm/Group Description Sorafenib and Dacarbazine in Soft Tissue Sarcoma
All-Cause Mortality
Soft Tissue Sarcoma Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Soft Tissue Sarcoma Patients
Affected / at Risk (%) # Events
Total   8/37 (21.62%)    
Blood and lymphatic system disorders   
Hemoglobin  1  2/37 (5.41%)  3
Hemorrhage/Bleeding, other  1  1/37 (2.70%)  2
Leukocytes (total WBC)  1  2/37 (5.41%)  2
Platelets  1  2/37 (5.41%)  3
General disorders   
Death not associated w CTCAE term- Death NOS  1  1/37 (2.70%)  1
Death not associated w CTCAE term-Disease progression NOS  1  1/37 (2.70%)  1
Fatigue (asthenia, lethargy, malaise)  1  1/37 (2.70%)  1
Pain - Extremity-limb  1  1/37 (2.70%)  1
Metabolism and nutrition disorders   
Sodium, low (hyponatremia)  1  1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders   
Obstruction of airway-Bronchus  1  1/37 (2.70%)  1
Thrombosis/thrombus/embolism  1  1/37 (2.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Soft Tissue Sarcoma Patients
Affected / at Risk (%) # Events
Total   30/37 (81.08%)    
Blood and lymphatic system disorders   
Hemoglobin  1  10/37 (27.03%)  10
Leukocytes (total WBC)  1  19/37 (51.35%)  19
Lymphopenia  1  14/37 (37.84%)  14
Neutrophils/granulocytes (ANC/AGC)  1  20/37 (54.05%)  20
Platelets  1  12/37 (32.43%)  12
Cardiac disorders   
Hypertension  1  2/37 (5.41%)  2
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  3/37 (8.11%)  3
Investigations   
Potassium, low (hypokalemia)  1  2/37 (5.41%)  2
Metabolism and nutrition disorders   
Albumin, low (hypoalbuminemia)  1  3/37 (8.11%)  3
Amylase  1  3/37 (8.11%)  3
Creatinine  1  3/37 (8.11%)  3
Glucose, high (hyperglycemia)  1  7/37 (18.92%)  7
Phosphate, low (hypophosphatemia)  1  15/37 (40.54%)  15
Sodium, low (hyponatremia)  1  2/37 (5.41%)  2
Skin and subcutaneous tissue disorders   
Rash: hand-foot skin reaction  1  7/37 (18.92%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. William Tap
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4163
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00837148     History of Changes
Other Study ID Numbers: 08-068
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015