Trial Outcomes & Findings for Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma (NCT NCT01281865)
NCT ID: NCT01281865
Last Updated: 2014-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
At 8 weeks
Results posted on
2014-10-08
Participant Flow
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
Participant milestones
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
2
|
|
Overall Study
COMPLETED
|
9
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
Baseline Characteristics
Everolimus in Combination With Imatinib Mesylate in Treating Patients With Locally Advanced, Locally Recurrent, or Metastatic Soft Tissue Sarcoma
Baseline characteristics by cohort
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
n=12 Participants
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
n=2 Participants
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
2 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksOutcome measures
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
n=9 Participants
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
n=1 Participants
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
|---|---|---|
|
Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)
Progression of Disease
|
4 participants
|
1 participants
|
|
Response Rate (CR + PR) Assessed by RECIST 1.1 (Phase II)
Stable Disease
|
5 participants
|
0 participants
|
Adverse Events
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
n=12 participants at risk
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
n=2 participants at risk
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
|---|---|---|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Neutrophil count decreased
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Sudden death NOS
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
Other adverse events
| Measure |
Arm 1-Treatment (Everolimus and Imatinib Mesylate)
n=12 participants at risk
Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
Arm 2-Treatment (Everolimus and Imatinib Mesylate)
n=2 participants at risk
Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
41.7%
5/12 • Number of events 28
|
100.0%
2/2 • Number of events 4
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
4/12 • Number of events 24
|
100.0%
2/2 • Number of events 6
|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
9/12 • Number of events 57
|
100.0%
2/2 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
58.3%
7/12 • Number of events 19
|
100.0%
2/2 • Number of events 6
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Cholesterol high
|
58.3%
7/12 • Number of events 45
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Creatinine increased
|
25.0%
3/12 • Number of events 19
|
0.00%
0/2
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
3/12 • Number of events 3
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Edema face
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
|
General disorders
Facial pain
|
0.00%
0/12
|
50.0%
1/2 • Number of events 2
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 7
|
100.0%
2/2 • Number of events 2
|
|
General disorders
Fever
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.0%
9/12 • Number of events 75
|
100.0%
2/2 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
66.7%
8/12 • Number of events 48
|
50.0%
1/2 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
4/12 • Number of events 27
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
2/12 • Number of events 2
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
41.7%
5/12 • Number of events 11
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
8/12 • Number of events 19
|
100.0%
2/2 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
33.3%
4/12 • Number of events 5
|
0.00%
0/2
|
|
Gastrointestinal disorders
Mucositis-oral
|
33.3%
4/12 • Number of events 4
|
100.0%
2/2 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 7
|
100.0%
2/2 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
25.0%
3/12 • Number of events 10
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Investigations
Platelet count decreased
|
75.0%
9/12 • Number of events 24
|
100.0%
2/2 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
3/12 • Number of events 5
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders Other, specify-dry split fingernails
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Skin infection
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
8.3%
1/12 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
50.0%
1/2 • Number of events 1
|
|
Investigations
White blood cell decreased
|
66.7%
8/12 • Number of events 47
|
0.00%
0/2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60