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Trial record 16 of 99 for:    "Sarcoma, Synovial"

Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT01281865
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : October 8, 2014
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Synovial Sarcoma
Recurrent Adult Soft Tissue Sarcoma
Stage III Adult Soft Tissue Sarcoma
Stage IV Adult Soft Tissue Sarcoma
Interventions Other: diagnostic laboratory biomarker analysis
Drug: everolimus
Drug: imatinib mesylate
Enrollment 14
Recruitment Details Protocol Open to Accrual: 01/20/2011 Protocol Closed to Accrual: 10/23/2012 Primary Completion Date (if applicable):10/22/2013 Recruitment Location is the medical clinic
Pre-assignment Details  
Arm/Group Title Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Hide Arm/Group Description Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Period Title: Overall Study
Started 12 2
Completed 9 1
Not Completed 3 1
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             1             0
Lack of Efficacy             1             0
Arm/Group Title Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate) Total
Hide Arm/Group Description Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD Total of all reporting groups
Overall Number of Baseline Participants 12 2 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 2 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  91.7%
2
 100.0%
13
  92.9%
>=65 years
1
   8.3%
0
   0.0%
1
   7.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 2 participants 14 participants
Female
6
  50.0%
1
  50.0%
7
  50.0%
Male
6
  50.0%
1
  50.0%
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 2 participants 14 participants
12 2 14
1.Primary Outcome
Title Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)
Hide Description [Not Specified]
Time Frame At 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Hide Arm/Group Description:
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
Overall Number of Participants Analyzed 9 1
Measure Type: Number
Unit of Measure: participants
Progression of Disease 4 1
Stable Disease 5 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Hide Arm/Group Description Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
All-Cause Mortality
Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      1/2 (50.00%)    
Gastrointestinal disorders     
Intra-abdominal hemorrhage  1  1/12 (8.33%)  1 0/2 (0.00%)  0
General disorders     
Sudden death NOS  1  0/12 (0.00%)  0 1/2 (50.00%)  1
Investigations     
Neutrophil count decreased  1  1/12 (8.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1-Treatment (Everolimus and Imatinib Mesylate) Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/12 (83.33%)      2/2 (100.00%)    
Blood and lymphatic system disorders     
Anemia  2  9/12 (75.00%)  57 2/2 (100.00%)  6
Gastrointestinal disorders     
Constipation  2  1/12 (8.33%)  1 1/2 (50.00%)  1
Diarrhea  2  3/12 (25.00%)  3 1/2 (50.00%)  1
Mucositis-oral  2  4/12 (33.33%)  4 2/2 (100.00%)  3
Nausea  2  2/12 (16.67%)  7 2/2 (100.00%)  3
Vomiting  2  0/12 (0.00%)  0 1/2 (50.00%)  1
General disorders     
Edema face  2  0/12 (0.00%)  0 1/2 (50.00%)  1
Facial pain  2  0/12 (0.00%)  0 1/2 (50.00%)  2
Fatigue  2  5/12 (41.67%)  7 2/2 (100.00%)  2
Fever  2  0/12 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations     
Skin infection  2  0/12 (0.00%)  0 1/2 (50.00%)  1
Investigations     
Alanine aminotransferase increased  1  5/12 (41.67%)  28 2/2 (100.00%)  4
Alkaline phosphatase increased  1  4/12 (33.33%)  24 2/2 (100.00%)  6
Aspartate aminotransferase increased  2  7/12 (58.33%)  19 2/2 (100.00%)  6
Blood bilirubin increased  2  2/12 (16.67%)  2 1/2 (50.00%)  1
Cholesterol high  2  7/12 (58.33%)  45 1/2 (50.00%)  1
Creatinine increased  2  3/12 (25.00%)  19 0/2 (0.00%)  0
Lymphocyte count decreased  2  4/12 (33.33%)  5 0/2 (0.00%)  0
Neutrophil count decreased  2  3/12 (25.00%)  10 0/2 (0.00%)  0
Platelet count decreased  2  9/12 (75.00%)  24 2/2 (100.00%)  5
White blood cell decreased  2  8/12 (66.67%)  47 0/2 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  2  1/12 (8.33%)  1 1/2 (50.00%)  1
Hyperglycemia  2  9/12 (75.00%)  75 2/2 (100.00%)  6
Hypernatremia  2  2/12 (16.67%)  2 0/2 (0.00%)  0
Hypertriglyceridemia  2  8/12 (66.67%)  48 1/2 (50.00%)  6
Hypoalbuminemia  2  4/12 (33.33%)  27 0/2 (0.00%)  0
Hypocalcemia  2  2/12 (16.67%)  2 0/2 (0.00%)  0
Hypokalemia  2  5/12 (41.67%)  11 1/2 (50.00%)  1
Hyponatremia  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Hypophosphatemia  2  8/12 (66.67%)  19 2/2 (100.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor pain  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Nervous system disorders     
Dysgeusia  2  0/12 (0.00%)  0 1/2 (50.00%)  1
Peripheral sensory neuropathy  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Dyspnea  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Pneumonitis  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders     
Papulopustular rash  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Rash maculo-papular  2  3/12 (25.00%)  5 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders Other, specify-dry split fingernails  2  1/12 (8.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
2
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Name/Title: Dr. Mary Keohan
Organization: Memorial Sloan-Kettering Cancer Center
Phone: 646-888-4160
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01281865     History of Changes
Other Study ID Numbers: NCI-2011-02577
NCI-2011-02577 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000693826
10-167 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8603 ( Other Identifier: CTEP )
P30CA008748 ( U.S. NIH Grant/Contract )
U01CA069856 ( U.S. NIH Grant/Contract )
First Submitted: January 21, 2011
First Posted: January 24, 2011
Results First Submitted: October 3, 2014
Results First Posted: October 8, 2014
Last Update Posted: October 8, 2014