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Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01051557
Recruitment Status : Terminated
First Posted : January 18, 2010
Results First Posted : April 18, 2016
Last Update Posted : December 6, 2017
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 Anaplastic Astrocytoma
Adult Anaplastic Oligodendroglioma
Adult Diffuse Astrocytoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma
Adult Oligodendroglioma
Recurrent Adult Brain Neoplasm
Interventions Other: Laboratory Biomarker Analysis
Drug: Perifosine
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Hide Arm/Group Description Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Period Title: Overall Study
Started 4 3 6 3 8 6 6
Completed 0 0 0 0 1 0 0
Not Completed 4 3 6 3 7 6 6
Reason Not Completed
Physician Decision             1             0             0             0             0             0             0
disease progression             3             3             5             2             4             3             1
Withdrawal by Subject             0             0             1             0             2             0             1
Adverse Event             0             0             0             1             1             3             4
Arm/Group Title 1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose ) Total
Hide Arm/Group Description Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Total of all reporting groups
Overall Number of Baseline Participants 4 3 6 3 8 6 6 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 3 participants 8 participants 6 participants 6 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
2
  66.7%
6
 100.0%
3
 100.0%
7
  87.5%
5
  83.3%
5
  83.3%
32
  88.9%
>=65 years
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  12.5%
1
  16.7%
1
  16.7%
4
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 6 participants 3 participants 8 participants 6 participants 6 participants 36 participants
Female
1
  25.0%
1
  33.3%
3
  50.0%
2
  66.7%
3
  37.5%
2
  33.3%
0
   0.0%
12
  33.3%
Male
3
  75.0%
2
  66.7%
3
  50.0%
1
  33.3%
5
  62.5%
4
  66.7%
6
 100.0%
24
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 6 participants 3 participants 8 participants 6 participants 6 participants 36 participants
4 3 6 3 8 6 6 36
1.Primary Outcome
Title Maximum Tolerated Dose of Temsirolimus
Hide Description MTD defined as the dose at which fewer than one-third of patients experience a dose limiting toxicity (DLT) according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Temsirolimus and Perifosine)
Hide Arm/Group Description:

PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery.

Overall Number of Participants Analyzed 36
Measure Type: Number
Unit of Measure: mg/week
115
2.Primary Outcome
Title Determine the Efficacy of Temsirolimus in Combination With Perifosine in Patients With Recurrent/Progressive Glioblastomas (GBMs) Not Taking EIAEDs as Measured by 6 Month Progression-free Survival (6mPFS) and Radiographic Response Rates. (Phase II)
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collect as as study did not progress to Phase II.
Arm/Group Title 1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Hide Arm/Group Description:
Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
Overall Number of Participants Analyzed 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Hide Arm/Group Description Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28 Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
All-Cause Mortality
1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/3 (66.67%)      1/6 (16.67%)      1/3 (33.33%)      3/8 (37.50%)      4/6 (66.67%)      3/6 (50.00%)    
Eye disorders               
Eye disorders - Other, specify  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
General disorders               
Gait disturbance  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Infections and infestations               
Device related infection  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations - Other, specify  1  0/4 (0.00%)  0 2/3 (66.67%)  2 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Lung infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1
Soft tissue infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Upper respiratory infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations               
Alanine aminotransferase increased  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Aspartate aminotransferase increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders               
Hyperglycemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders               
Muscle weakness left-sided  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nervous system disorders               
Seizure  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Headache  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Intracranial hemorrhage  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders               
Rash maculo-papular  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Vascular disorders               
Thromboembolic event  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Hypertension  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (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 0%
1 (Temsirolimus: 15 mg/wk) 2 (Temsirolimus: 25 mg/wk) 3 (Temsirolimus: 50 mg/wk) 4 (Temsirolimus: 75 mg/wk) 5 (Temsirolimus: 115 mg/wk) 6 (Temsirolimus: 170 mg/wk) 7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      2/3 (66.67%)      6/6 (100.00%)      3/3 (100.00%)      7/8 (87.50%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders               
Anemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Eye disorders               
Eye infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders               
Anal mucositis  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Mucositis oral  1  1/4 (25.00%)  2 0/3 (0.00%)  0 2/6 (33.33%)  2 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 4/6 (66.67%)  5
Diarrhea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  1 0/8 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
Dyspepsia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/3 (66.67%)  2 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hemorrhoids  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Vomiting  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
General disorders               
Fatigue  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/3 (33.33%)  2 0/8 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Edema limbs  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations               
Papulopustular rash  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Tooth infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/8 (25.00%)  3 0/6 (0.00%)  0 0/6 (0.00%)  0
Upper respiratory infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Soft tissue infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Mucosal infection  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations               
Blood bilirubin increased  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 1/6 (16.67%)  3 0/6 (0.00%)  0
Cholesterol high  1  1/4 (25.00%)  3 2/3 (66.67%)  6 1/6 (16.67%)  2 2/3 (66.67%)  8 2/8 (25.00%)  13 3/6 (50.00%)  6 3/6 (50.00%)  6
Alanine aminotransferase increased  1  0/4 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/3 (33.33%)  4 3/8 (37.50%)  19 1/6 (16.67%)  1 2/6 (33.33%)  4
Lymphocyte count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0 2/8 (25.00%)  3 2/6 (33.33%)  15 1/6 (16.67%)  2
Neutrophil count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  8 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
Platelet count decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 0/3 (0.00%)  0 1/8 (12.50%)  1 2/6 (33.33%)  5 2/6 (33.33%)  7
White blood cell decreased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  8 1/3 (33.33%)  2 3/8 (37.50%)  5 0/6 (0.00%)  0 1/6 (16.67%)  1
Aspartate aminotransferase increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  6 0/6 (0.00%)  0 1/6 (16.67%)  2
CPK increased  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders               
Hypertriglyceridemia  1  1/4 (25.00%)  1 1/3 (33.33%)  2 1/6 (16.67%)  2 1/3 (33.33%)  5 4/8 (50.00%)  6 3/6 (50.00%)  4 3/6 (50.00%)  4
Hypophosphatemia  1  1/4 (25.00%)  2 1/3 (33.33%)  1 4/6 (66.67%)  9 3/3 (100.00%)  4 3/8 (37.50%)  5 4/6 (66.67%)  6 1/6 (16.67%)  7
Hypocalcemia  1  0/4 (0.00%)  0 1/3 (33.33%)  4 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hyperglycemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 1/3 (33.33%)  2 3/8 (37.50%)  12 2/6 (33.33%)  4 2/6 (33.33%)  12
Hypokalemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  2 0/8 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Hyperkalemia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Anorexia  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders               
Pain in extremity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders               
Headache  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders               
Ejaculation disorder  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders               
Dyspnea  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/3 (33.33%)  1 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders               
Dry skin  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Rash acneiform  1  1/4 (25.00%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Photosensitivity  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Pruritus  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin & subcutaneous tissue disorders Other, spec  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin ulceration  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 1/8 (12.50%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Rash maculo-papular  1  0/4 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/3 (0.00%)  0 0/8 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
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. Thomas Kaley
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5122
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01051557     History of Changes
Other Study ID Numbers: NCI-2011-01409
NCI-2011-01409 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MSKCC-09058
09-058
CDR0000663573
09-058 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
8249 ( Other Identifier: CTEP )
P30CA008748 ( U.S. NIH Grant/Contract )
U01CA069856 ( U.S. NIH Grant/Contract )
First Submitted: January 15, 2010
First Posted: January 18, 2010
Results First Submitted: March 17, 2016
Results First Posted: April 18, 2016
Last Update Posted: December 6, 2017