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Trial of Dasatinib in Advanced Sarcomas

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ClinicalTrials.gov Identifier: NCT00464620
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rhabdomyosarcoma
Malignant Peripheral Nerve Sheath Tumors
Chondrosarcoma
Sarcoma, Ewing's
Sarcoma, Alveolar Soft Part
Chordoma
Epithelioid Sarcoma
Giant Cell Tumor of Bone
Hemangiopericytoma
Gastrointestinal Stromal Tumor (GIST)
Intervention Drug: Dasatinib
Enrollment 366
Recruitment Details 50 patients with GIST were enrolled between June 2008 and December 2009 and 48 were evaluable for response. Between May 2007 and May 2009, 200 patients with advanced, high-grade sarcoma were enrolled into the aggressive subtype for this study. 116 patients were registered beginning in July 2007 to the indolent subtype for this study.
Pre-assignment Details  
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Period Title: Overall Study
Started 50 200 116
Completed 48 [1] 198 109
Not Completed 2 2 7
Reason Not Completed
Physician Decision             1             0             0
Withdrawal by Subject             1             0             3
Ineligible sarcoma subtype             0             2             2
Use of prohibited concomitant medication             0             0             2
[1]
48 patients were evaluable.
Arm/Group Title Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Baseline Participants 359
Hide Baseline Analysis Population Description
116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. Baseline characteristics for the Indolent subtype were based off of 109 subjects on treatment. This explains the discrepancy between the Participant Flow and the Overall Number of Baseline Participants.
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Aggressive subtype Number Analyzed 200 participants
52
(14.8 to 87.3)
GIST Number Analyzed 50 participants
60
(19 to 78)
Indolent Number Analyzed 109 participants
54
(22 to 87)
[1]
Measure Analysis Population Description: The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Aggressive subtype Number Analyzed 200 participants
Female
96
  48.0%
Male
104
  52.0%
GIST Number Analyzed 50 participants
Female
19
  38.0%
Male
31
  62.0%
Indolent Number Analyzed 109 participants
Female
33
  30.3%
Male
76
  69.7%
[1]
Measure Analysis Population Description: The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Aggressive subtype Number Analyzed 200 participants
White
171
  85.5%
Black
15
   7.5%
Asian
6
   3.0%
Other
6
   3.0%
Unknown
2
   1.0%
Native American
0
   0.0%
GIST Number Analyzed 50 participants
White
41
  82.0%
Black
3
   6.0%
Asian
3
   6.0%
Other
1
   2.0%
Unknown
1
   2.0%
Native American
1
   2.0%
Indolent Number Analyzed 109 participants
White
94
  86.2%
Black
8
   7.3%
Asian
3
   2.8%
Other
4
   3.7%
Unknown
0
   0.0%
Native American
0
   0.0%
[1]
Measure Analysis Population Description: The baseline measurements are categorized by the three different subtypes from the protocol (aggressive, indolent and GIST).
1.Primary Outcome
Title Response Rate: Number of Participants With Objective Tumor Response
Hide Description Assessment of objective tumor response for response rate with MRI or CT using Choi criteria: Complete Remission (CR) Complete disappearance of all measurable and evaluable disease for at least 4 weeks; Partial Remission (PR) A 10% or greater decrease from the baseline in the sum of the largest diameters of all measurable target lesions.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
116 subjects enrolled in the Indolent subtype, however 109 subjects began treatment. 50 patients enrolled in the GIST subtype, however 48 patients were evaluable. This explains the discrepancy between Overall Number of Participants Analyzed.
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 48 198 109
Measure Type: Count of Participants
Unit of Measure: Participants
12
  25.0%
14
   7.1%
20
  18.3%
2.Primary Outcome
Title 6 Month Progression-free Survival Rate of "Indolent" Sarcomas Treated With Dasatinib
Hide Description Estimate the 6 month progression-free survival rate of "indolent" sarcomas treated with dasatinib. Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indolent Subtypes: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 109
Measure Type: Count of Participants
Unit of Measure: Participants
52
  47.7%
3.Primary Outcome
Title 6 Month Progression-free Survival Rate of Gastrointestinal Stromal Tumors (GIST)
Hide Description To estimate the 6 month progression-free survival rate of gastrointestinal stromal tumors (GIST). Progression is defined using Choi criteria, as a 10% or greater increase in the sum of all measurable target lesions over the smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or unequivocal reappearance of any lesion which had disappeared, or appearance of any new lesions of greater than double slice thickness in size, or any new or enlarging solid nodule in a previously hypodense treated mass.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
14
  29.2%
4.Secondary Outcome
Title Median Time-to-progression of Subjects With GIST Treated With Dasatinib.
Hide Description To estimate the median time-to-progression of subjects with GIST treated with dasatinib.
Time Frame Up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 48
Median (Full Range)
Unit of Measure: months
2.9
(2 to 5.5)
5.Secondary Outcome
Title Overall Survival Rates at 2 and 5 Years From Registration of Subjects Treated With Dasatinib.
Hide Description To estimate the overall survival rates at 2 and 5 years from registration of subjects treated with dasatinib.
Time Frame At 2 and 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 48 109
Measure Type: Count of Participants
Unit of Measure: Participants
2 years overall survival
21
  43.8%
48
  44.0%
5 years overall survival
8
  16.7%
14
  12.8%
6.Secondary Outcome
Title Median Time-to-progression of Subjects With "Indolent" Sarcomas Treated With Dasatinib.
Hide Description To estimate the median time-to-progression of subjects with "indolent" sarcomas treated with dasatinib.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 109
Median (Full Range)
Unit of Measure: months
5.8
(3.7 to 7.4)
7.Secondary Outcome
Title 6 Month Progression-free Survival Rate of Subjects Enrolled in the Aggressive Subtype.
Hide Description To estimate the 6 month progression-free survival rate of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, Malignant fibrous histiocytoma (MFH), rhabdomyosarcoma and MPNST treated with dasatinib.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The numbers analyzed in one or more rows are different because they are broken up by cohorts.
Arm/Group Title Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 198
Measure Type: Count of Participants
Unit of Measure: Participants
UPS Number Analyzed 48 participants
6
  12.5%
Leiomyosarcoma Number Analyzed 49 participants
5
  10.2%
Osteosarcoma Number Analyzed 46 participants
5
  10.9%
Rhabdomyosarcoma Number Analyzed 13 participants
0
   0.0%
Ewing's Sarcoma Number Analyzed 17 participants
1
   5.9%
Liposarcoma Number Analyzed 11 participants
0
   0.0%
MPNST Number Analyzed 14 participants
0
   0.0%
8.Secondary Outcome
Title Median Time-to-progression of Subjects Enrolled in the Aggressive Subtype.
Hide Description To estimate the median time-to-progression of subjects with leiomyosarcoma, liposarcoma, osteosarcoma including high-grade chondrosarcomas, Ewing's sarcoma, MFH, rhabdomyosarcoma and MPNST treated with dasatinib.
Time Frame Up to 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 198
Median (Full Range)
Unit of Measure: months
1.9
(0.9 to 2.2)
9.Secondary Outcome
Title Overall Survival Rates at 2 and 5 Years From Registration of Subjects Enrolled in the Aggressive Subtype Treated With Dasatinib.
Hide Description To estimate the overall survival rates at 2 and 5 years from registration of subjects enrolled in the aggressive subtype treated with dasatinib.
Time Frame At 2 and 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed in one or more rows differs from overall number because the rows are broken down into cohorts. The counts in the categories will not add up to the number analyzed, because those numbers represent number of participants that have reached overall survival at 2 and 5 years.
Arm/Group Title Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 198
Measure Type: Number
Unit of Measure: participants
Ewing's Sarcoma : 2 year overall survival rate Number Analyzed 17 participants
7
Ewing's Sarcoma : 5 year overall survival rate Number Analyzed 7 participants
0
Leiomyosarcoma : 2 year overall survival rate Number Analyzed 49 participants
21
Leiomyosarcoma : 5 year overall survival rate Number Analyzed 21 participants
2
Liposarcoma : 2 year overall survival rate Number Analyzed 11 participants
0
Liposarcoma : 5 year overall survival rate Number Analyzed 11 participants
0
MPNST : 2 year overall survival rate Number Analyzed 14 participants
0
MPNST : 5 year overall survival rate Number Analyzed 14 participants
0
Osteosarcoma : 2 year overall survival rate Number Analyzed 46 participants
15
Osteosarcoma : 5 year overall survival rate Number Analyzed 15 participants
0
Rhabdomyosarcoma : 2 year overall survival rate Number Analyzed 13 participants
8
Rhabdomyosarcoma : 5 year overall survival rate Number Analyzed 8 participants
7
UPS : 2 year overall survival rate Number Analyzed 48 participants
26
UPS : 5 year overall survival rate Number Analyzed 26 participants
6
10.Secondary Outcome
Title Uni-dimensional and Bi-dimensional Tumor Size, Tumor Volumes and Tumor Average Density Determined by Computer-aided Automated Detection in a Subset of Subjects With Tumor Predominately Involving the Lung
Hide Description To prospectively collect uni-dimensional and bi-dimensional tumor size, tumor volumes and tumor average density determined by computer-aided automated detection in a subset of subjects with tumor predominately involving the lung
Time Frame Up to 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected because the imaging software and work station was not obtained.
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Plasma Level of Dasatinib and Inhibition of SRC and/or Focal Adhesion Kinase (FAK) in Peripheral Blood Mononuclear Cells
Hide Description Obtain blood samples to characterize plasma level of dasatinib and inhibition of SRC and/or FAK in peripheral blood mononuclear cells 2 hours after ingestion of drug at 2-4 weeks from the start of treatment if activity of the drug in a sarcoma subtype warrants further study.
Time Frame 2-4 weeks from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluation of blood levels of drug was not performed because there was insufficient activity and the level of activity did not warrant further study.
Arm/Group Title GIST: Dasatinib, 70 mg, Twice Daily Aggressive Subtypes: Dasatinib, 70 mg, Twice Daily Indolent Subtype: Dasatinib, 70 mg, Twice Daily
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Number of Participants With Tumors With Kinase Expression
Hide Description Obtain tumor tissue for creation of tissue microarrays to examine the frequency of kinase expression such as SRC and/or FAK in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing’s, Alveolar soft part sarcoma (ASPS), chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma, and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the number of participants who had tissue that was able to generate tissue microarray for kinase expression.
Time Frame Up to 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed demonstrates the number of participants whose tumor samples received. The results illustrate the tissue that was able to generate tissue microarray for SRC and FAK analysis.
Arm/Group Title Osteosarcoma Leiomyosarcoma MFH/Undifferentiated Pleomorphic Sarcoma
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 32 44 37
Measure Type: Count of Participants
Unit of Measure: Participants
11
  34.4%
24
  54.5%
16
  43.2%
13.Secondary Outcome
Title Number of Participants With Tumors With Mutations in Kinases
Hide Description Obtain tumor tissue to examine the frequency of mutations in kinases such as PDGFR in leiomyosarcoma, liposarcoma, osteosarcoma, MFH, rhabdomyosarcoma, MPNST, chondrosarcoma, Ewing’s, ASPS, chordoma, epithelioid sarcoma, giant cell tumor of bone, hemangiopericytoma and GIST if activity of the drug in a subtype warrants further study. The outcome measure demonstrates the tissue that was able to generate tissue microarray for PDGFR analysis.
Time Frame Up to 37 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The overall number of participants analyzed demonstrates the number of participants whose tumor samples were received. The results illustrate the tissue that was able to generate tissue microarray for PDGFR analysis.
Arm/Group Title Osteosarcoma Leiomyosarcoma MFH/Undifferentiated Pleomorphic Sarcoma
Hide Arm/Group Description:

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

Overall Number of Participants Analyzed 32 44 37
Measure Type: Count of Participants
Unit of Measure: Participants
11
  34.4%
24
  54.5%
16
  43.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GIST, Aggressive, Indolent Subtypes
Hide Arm/Group Description

Patients take 70 mg of Dasatinib, twice daily, for 28 day cycles

Dasatinib: oral agent, continuous dosing, Cycles = 28 days

All-Cause Mortality
GIST, Aggressive, Indolent Subtypes
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GIST, Aggressive, Indolent Subtypes
Affected / at Risk (%) # Events
Total   158/355 (44.51%)    
Blood and lymphatic system disorders   
Blood-other   1/355 (0.28%)  1
Cardiac disorders   
Pericardial effusion   1/355 (0.28%)  1
Ventricular tachycardia   1/355 (0.28%)  1
Cardiac ischemia/infarction   1/355 (0.28%)  1
Congestive heart failure   2/355 (0.56%)  2
Atrial Fibrillation   2/355 (0.56%)  2
Gastrointestinal disorders   
Colitis   4/355 (1.13%)  4
Constipation   4/355 (1.13%)  4
Diarrhea   8/355 (2.25%)  11
Distention   1/355 (0.28%)  1
Esophagitis   1/355 (0.28%)  1
Gastritis   1/355 (0.28%)  1
GI Hemorrhage: lower GI   2/355 (0.56%)  2
GI Hemorrhage: upper GI   2/355 (0.56%)  2
GI Obstruction: small bowel   6/355 (1.69%)  6
GI Obstruction: stomach   1/355 (0.28%)  1
GI Pain: abdomen   12/355 (3.38%)  12
GI Ulcer: colon   1/355 (0.28%)  1
GI- other   1/355 (0.28%)  1
Nausea   18/355 (5.07%)  20
Vomiting   17/355 (4.79%)  19
GI Hemorrhage- abdomen   1/355 (0.28%)  1
GI Hemorrhage- esophagus   1/355 (0.28%)  1
GI Hemorrhage- rectum   2/355 (0.56%)  2
GI Hemorrhage- stomach   1/355 (0.28%)  1
Pancreatitis   1/355 (0.28%)  1
General disorders   
Constitutional symptoms-other   1/355 (0.28%)  1
Death, NOS   4/355 (1.13%)  4
Disease progression, NOS   7/355 (1.97%)  7
Fatigue   7/355 (1.97%)  7
Fever   15/355 (4.23%)  16
Flu-like syndrome   1/355 (0.28%)  1
Hemorrhage-other   2/355 (0.56%)  2
Pain   5/355 (1.41%)  5
Sudden death   1/355 (0.28%)  1
Multi-organ failure   1/355 (0.28%)  1
Rigors/chills   1/355 (0.28%)  1
Edema- limb   4/355 (1.13%)  4
Gait/walking   1/355 (0.28%)  1
Hepatobiliary disorders   
Cholecystitis   1/355 (0.28%)  1
Immune system disorders   
Allergic reaction   1/355 (0.28%)  1
Infections and infestations   
Infection, Unk ANC: blood   2/355 (0.56%)  2
Infection-other   5/355 (1.41%)  6
Lung infection, 0-2 ANC: bronchus   1/355 (0.28%)  1
Lung Infection, 3-4 ANC: bronchus   1/355 (0.28%)  1
Lung Infection, Unk ANC: lung   1/355 (0.28%)  1
Injury, poisoning and procedural complications   
Fracture   3/355 (0.85%)  3
Investigations   
ALT   2/355 (0.56%)  4
Amylase   1/355 (0.28%)  1
AST   2/355 (0.56%)  2
Bilirubin   1/355 (0.28%)  1
Coagulation-other   1/355 (0.28%)  1
Creatinine   5/355 (1.41%)  5
Hemoglobin   14/355 (3.94%)  15
Leukocytes   1/355 (0.28%)  1
Neutrophils   2/355 (0.56%)  2
Platelets   1/355 (0.28%)  1
Lymphopenia   1/355 (0.28%)  1
Metabolism and nutrition disorders   
Anorexia   4/355 (1.13%)  4
Dehydration   11/355 (3.10%)  11
Hyperkalemia   2/355 (0.56%)  2
Hyponatremia   5/355 (1.41%)  5
Hypokalemia   3/355 (0.85%)  3
Lipase   1/355 (0.28%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness   6/355 (1.69%)  6
Musculo. Pain   17/355 (4.79%)  17
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain   4/355 (1.13%)  4
Nervous system disorders   
CNS hemorrhage   4/355 (1.13%)  4
Neuropathy- sensory   1/355 (0.28%)  1
Seizure   1/355 (0.28%)  1
Syncope   1/355 (0.28%)  1
Myelitis   1/355 (0.28%)  1
Ataxia   1/355 (0.28%)  1
Dizziness   1/355 (0.28%)  1
Headache   2/355 (0.56%)  2
Psychiatric disorders   
Confusion   3/355 (0.85%)  3
Anxiety   1/355 (0.28%)  1
Renal and urinary disorders   
GU Hemorrhage: urinary   2/355 (0.56%)  2
GU Hemorrhage: vagina   1/355 (0.28%)  1
GU Infection, 0-2 ANC: urinary tract   1/355 (0.28%)  1
GU Infection, Unk ANC: ureter   1/355 (0.28%)  1
GU Pain: kidney   1/355 (0.28%)  1
Incontinence, urinary   1/355 (0.28%)  1
Renal failure   5/355 (1.41%)  5
Urinary retention   1/355 (0.28%)  1
Renal failure   7/355 (1.97%)  7
Reproductive system and breast disorders   
Reproductive pain: pelvis   1/355 (0.28%)  1
Pelvis pain   1/355 (0.28%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration   1/355 (0.28%)  1
Dyspnea   34/355 (9.58%)  37
Hypoxia   5/355 (1.41%)  5
Lung Pain   8/355 (2.25%)  8
Pleural effusion   30/355 (8.45%)  34
Pneumonitis   3/355 (0.85%)  3
Pulmonary-other   8/355 (2.25%)  9
Cough   2/355 (0.56%)  2
Skin and subcutaneous tissue disorders   
Dermatology- other   1/355 (0.28%)  1
Rash   2/355 (0.56%)  2
Vascular disorders   
Hypertension   1/355 (0.28%)  1
Hypotension   2/355 (0.56%)  2
Thrombosis/embolism   6/355 (1.69%)  6
Hypertension   2/355 (0.56%)  2
Hypotension   4/355 (1.13%)  4
Sweating   1/355 (0.28%)  1
Hematoma   1/355 (0.28%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GIST, Aggressive, Indolent Subtypes
Affected / at Risk (%) # Events
Total   314/355 (88.45%)    
Blood and lymphatic system disorders   
Thrombocytopenia   19/355 (5.35%)  31
Anemia   70/355 (19.72%)  103
Petechiae   1/355 (0.28%)  1
Lymph node pain   1/355 (0.28%)  1
Cardiac disorders   
Palpaitations   2/355 (0.56%)  2
Prolonged QTc   4/355 (1.13%)  4
Pericardial effusion   4/355 (1.13%)  4
Cardiac- Other   4/355 (1.13%)  5
Atrial Tachycardia   1/355 (0.28%)  1
Sinus Bradycardia   1/355 (0.28%)  1
Ear and labyrinth disorders   
Auditory/Ear- Other   1/355 (0.28%)  1
Eye disorders   
Dry eye   1/355 (0.28%)  1
Blurred vision   1/355 (0.28%)  1
Diplopia   1/355 (0.28%)  1
Ocular- Other   4/355 (1.13%)  5
Eye pain   1/355 (0.28%)  1
Gastrointestinal disorders   
Constipation   27/355 (7.61%)  27
Diarrhea   73/355 (20.56%)  99
Nausea   81/355 (22.82%)  93
Vomiting   36/355 (10.14%)  38
GI Pain: abdomen   15/355 (4.23%)  22
Heartburn   9/355 (2.54%)  10
Distention   3/355 (0.85%)  3
Dehydration   5/355 (1.41%)  5
Dry mouth   3/355 (0.85%)  3
Taste alteration   8/355 (2.25%)  8
Gastritis   3/355 (0.85%)  3
Dysphagia   4/355 (1.13%)  4
Ascites   1/355 (0.28%)  1
Flatulence   6/355 (1.69%)  6
Hemorrhoids   6/355 (1.69%)  9
Gastrointestinal- Other   7/355 (1.97%)  7
Mucositis   4/355 (1.13%)  4
Fistula   1/355 (0.28%)  1
GI Hemorrhage   9/355 (2.54%)  10
GI Pain   15/355 (4.23%)  22
General disorders   
Edema   34/355 (9.58%)  50
Fatigue   113/355 (31.83%)  144
Fever   27/355 (7.61%)  29
Pain- Other   17/355 (4.79%)  17
Rigors/chills   16/355 (4.51%)  18
Flu-like syndrome   3/355 (0.85%)  3
Hepatobiliary disorders   
Hepatic pain   1/355 (0.28%)  1
Immune system disorders   
Allergic reaction   1/355 (0.28%)  1
Infections and infestations   
Lung Infection   14/355 (3.94%)  16
GU Infection   4/355 (1.13%)  4
GI Infection   8/355 (2.25%)  11
Skin Infection   1/355 (0.28%)  1
Eye Infection   1/355 (0.28%)  1
Injury, poisoning and procedural complications   
Bruising   2/355 (0.56%)  2
Wound complication   1/355 (0.28%)  1
Investigations   
Weight loss   17/355 (4.79%)  17
Elevated PTT   3/355 (0.85%)  4
Leukopenia   13/355 (3.66%)  19
Neutropenia   15/355 (4.23%)  28
Lymphopenia   11/355 (3.10%)  12
Metabolism and nutrition disorders   
Anorexia   45/355 (12.68%)  49
Hyperglycemia   25/355 (7.04%)  41
Hyponatremia   14/355 (3.94%)  18
Hypernatremia   1/355 (0.28%)  1
Elevated Alkaline phosphatase   15/355 (4.23%)  15
Elevated ALT   7/355 (1.97%)  9
Elevated AST   7/355 (1.97%)  10
Elevated serum bilirubin   2/355 (0.56%)  2
Elevated creatinine   11/355 (3.10%)  14
Hypoalbuminemia   5/355 (1.41%)  5
Hypokalemia   6/355 (1.69%)  6
Hyperkalemia   6/355 (1.69%)  6
Acidosis   1/355 (0.28%)  1
Hypoglycemia   2/355 (0.56%)  2
Low serum bicarbonate   2/355 (0.56%)  2
Hypocalcemia   7/355 (1.97%)  10
Hypercalcemia   3/355 (0.85%)  3
Hypermagnesemia   9/355 (2.54%)  10
Elevated lipase   1/355 (0.28%)  1
Hypophosphatemia   5/355 (1.41%)  7
Musculoskeletal and connective tissue disorders   
Muscle weakness   7/355 (1.97%)  8
Musculoskeletal pain   67/355 (18.87%)  100
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor Pain   10/355 (2.82%)  11
Nervous system disorders   
Headache   52/355 (14.65%)  68
CNS Hemorrhage   2/355 (0.56%)  2
Somnolence   1/355 (0.28%)  1
Seizure   1/355 (0.28%)  1
Cognitive disturbance   1/355 (0.28%)  1
Tremor   1/355 (0.28%)  1
Ataxia   1/355 (0.28%)  1
Involuntary movement   3/355 (0.85%)  3
Sensory neuropathy   8/355 (2.25%)  8
Leukoencephalopathy   1/355 (0.28%)  1
Dizziness   8/355 (2.25%)  10
Psychiatric disorders   
Insomnia   8/355 (2.25%)  8
Confusion   4/355 (1.13%)  4
Agitation   3/355 (0.85%)  3
Anxiety   4/355 (1.13%)  5
Depression   7/355 (1.97%)  8
Renal and urinary disorders   
Urinary incontinence   1/355 (0.28%)  1
Cystitis   1/355 (0.28%)  1
Urinary retention   2/355 (0.56%)  2
Urinary frequency   4/355 (1.13%)  4
Urine color change   1/355 (0.28%)  1
Bladder spasms   2/355 (0.56%)  2
Renal - Other   5/355 (1.41%)  5
Ureter obstruction   1/355 (0.28%)  1
GU Hemorrhage   3/355 (0.85%)  5
Reproductive system and breast disorders   
Pelvis pain   4/355 (1.13%)  4
Breast pain   2/355 (0.56%)  2
Respiratory, thoracic and mediastinal disorders   
Cough   45/355 (12.68%)  55
Dyspnea   56/355 (15.77%)  78
Pleural effusion   43/355 (12.11%)  60
Atelectasis   1/355 (0.28%)  1
Hypoxia   1/355 (0.28%)  1
Pneumonitis   1/355 (0.28%)  1
Voice alteration   4/355 (1.13%)  4
Pulmonary- Other   9/355 (2.54%)  12
Lung Pain   17/355 (4.79%)  18
Skin and subcutaneous tissue disorders   
Rash   52/355 (14.65%)  64
Urticaria   1/355 (0.28%)  2
Pruritus   5/355 (1.41%)  5
Acne   3/355 (0.85%)  3
Hyperpigmentation   1/355 (0.28%)  1
Hypopigmentation   3/355 (0.85%)  3
Alopecia   2/355 (0.56%)  2
Skin pain   1/355 (0.28%)  1
Dermatology- Other   8/355 (2.25%)  9
Vascular disorders   
Hypertension   5/355 (1.41%)  6
Hot flashes   3/355 (0.85%)  4
Sweating   8/355 (2.25%)  9
Flushing   5/355 (1.41%)  5
Phlebitis   1/355 (0.28%)  1
Thrombosis/embolism   1/355 (0.28%)  1
Vascular- Other   1/355 (0.28%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SARC
Organization: SARC
Phone: (734) 930-7600
EMail: sarc@sarctrials.org
Layout table for additonal information
Responsible Party: Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier: NCT00464620     History of Changes
Other Study ID Numbers: SARC009
First Submitted: April 20, 2007
First Posted: April 23, 2007
Results First Submitted: August 3, 2018
Results First Posted: November 22, 2018
Last Update Posted: November 22, 2018