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Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

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ClinicalTrials.gov Identifier: NCT01653028
Recruitment Status : Completed
First Posted : July 30, 2012
Results First Posted : December 28, 2016
Last Update Posted : November 30, 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 Myxofibrosarcoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Leiomyosarcoma
Recurrent Liposarcoma
Recurrent Malignant Peripheral Nerve Sheath Tumor
Recurrent Undifferentiated Pleomorphic Sarcoma
Stage III Soft Tissue Sarcoma AJCC v7
Stage IV Soft Tissue Sarcoma AJCC v7
Interventions Drug: Alisertib
Other: Laboratory Biomarker Analysis
Enrollment 72
Recruitment Details From August 2012 to April 2014, a total of 72 patients were accrued to this study (Cohort 1 – 12, Cohort 2 – 10, Cohort 3 – 11, Cohort 4 – 10 Cohort 5 – 29) at a rate of 4.5 patients per month.
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5
Hide Arm/Group Description Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 12 10 11 10 29
Completed 12 10 11 10 29
Not Completed 0 0 0 0 0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5 Total
Hide Arm/Group Description Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 12 10 11 10 29 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 11 participants 10 participants 29 participants 72 participants
61
(40 to 72)
56.5
(39 to 84)
66
(49 to 76)
52.5
(29 to 71)
49
(20 to 83)
54.5
(20 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 11 participants 10 participants 29 participants 72 participants
Female
7
  58.3%
3
  30.0%
5
  45.5%
4
  40.0%
14
  48.3%
33
  45.8%
Male
5
  41.7%
7
  70.0%
6
  54.5%
6
  60.0%
15
  51.7%
39
  54.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 11 participants 10 participants 29 participants 72 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
1
   1.4%
Asian
2
  16.7%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
3
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
2
  18.2%
2
  20.0%
2
   6.9%
6
   8.3%
White
10
  83.3%
10
 100.0%
9
  81.8%
7
  70.0%
25
  86.2%
61
  84.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
1
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 11 participants 10 participants 29 participants 72 participants
12 10 11 10 29 72
1.Primary Outcome
Title The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.
Hide Description The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.
Time Frame Up to 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description:
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12 10 11 10 29
Measure Type: Number
Unit of Measure: percentage of patients with response
0 0 0 0 7
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).
Time Frame The time between registration and death, assessed up to 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description:
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12 10 11 10 29
Median (95% Confidence Interval)
Unit of Measure: Weeks
NA [1] 
(23.3 to NA)
71.7 [1] 
(16 to NA)
67.8 [1] 
(19 to NA)
69 [1] 
(16 to NA)
28.6
(16.6 to 51.3)
[1]
Not Reached
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).
Time Frame The time between registration to disease progression or death, assessed up to 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description:
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12 10 11 10 29
Median (95% Confidence Interval)
Unit of Measure: Weeks
13
(6.29 to 37.1)
11.7
(1.71 to 21.9)
11.7
(5 to 20.6)
13.2
(3.57 to 45)
6.57
(5.86 to 18.1)
4.Secondary Outcome
Title Adverse Events
Hide Description Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.
Time Frame During treatment and up to 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients that began study treatment were assessed for this endpoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5
Hide Arm/Group Description:
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 12 10 11 10 29
Measure Type: Number
Unit of Measure: participants
Grade 4 Event 6 1 5 0 4
Grade 5 Event 0 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5
Hide Arm/Group Description Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/12 (16.67%)      2/10 (20.00%)      1/11 (9.09%)      4/10 (40.00%)      13/29 (44.83%)    
Blood and lymphatic system disorders           
Anemia  1  1/12 (8.33%)  1 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Febrile neutropenia  1  1/12 (8.33%)  2 1/10 (10.00%)  1 1/11 (9.09%)  2 0/10 (0.00%)  0 2/29 (6.90%)  2
Gastrointestinal disorders           
Abdominal pain  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Colonic fistula  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Diarrhea  1  2/12 (16.67%)  3 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Duodenal obstruction  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Mucositis oral  1  2/12 (16.67%)  3 2/10 (20.00%)  2 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Nausea  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 2/29 (6.90%)  3
Typhlitis  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Vomiting  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 4/29 (13.79%)  5
General disorders           
Fatigue  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations           
Lung infection  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  2
Sepsis  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Wound infection  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Investigations           
Blood bilirubin increased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
INR increased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Neutrophil count decreased  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 4/29 (13.79%)  5
Platelet count decreased  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  2
Serum amylase increased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
White blood cell decreased  1  1/12 (8.33%)  1 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Metabolism and nutrition disorders           
Anorexia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Dehydration  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Hyperkalemia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Hyponatremia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders           
Head soft tissue necrosis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Bronchopulmonary hemorrhage  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  2
Respiratory failure  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders           
Palmar-plantar erythrodysesthesia syndrome  1  2/12 (16.67%)  2 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Rash maculo-papular  1  1/12 (8.33%)  2 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Vascular disorders           
Thromboembolic event  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2 Cohort 3 Cohort4 Cohort 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      8/10 (80.00%)      11/11 (100.00%)      9/10 (90.00%)      28/29 (96.55%)    
Blood and lymphatic system disorders           
Anemia  1  10/12 (83.33%)  32 4/10 (40.00%)  15 7/11 (63.64%)  44 6/10 (60.00%)  15 15/29 (51.72%)  37
Febrile neutropenia  1  1/12 (8.33%)  1 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 2/29 (6.90%)  2
Leukocytosis  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Cardiac disorders           
Sinus tachycardia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Eye disorders           
Blurred vision  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  4
Dry eye  1  1/12 (8.33%)  3 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Eye pain  1  1/12 (8.33%)  4 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Watering eyes  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Gastrointestinal disorders           
Abdominal pain  1  1/12 (8.33%)  1 1/10 (10.00%)  3 1/11 (9.09%)  2 0/10 (0.00%)  0 1/29 (3.45%)  2
Anal mucositis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Colonic hemorrhage  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 0/29 (0.00%)  0
Constipation  1  1/12 (8.33%)  1 1/10 (10.00%)  4 1/11 (9.09%)  2 3/10 (30.00%)  3 3/29 (10.34%)  12
Diarrhea  1  4/12 (33.33%)  9 2/10 (20.00%)  5 4/11 (36.36%)  15 6/10 (60.00%)  16 11/29 (37.93%)  28
Dyspepsia  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Dysphagia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 2/29 (6.90%)  2
Gastroesophageal reflux disease  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 1/29 (3.45%)  1
Hemorrhoidal hemorrhage  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Mucositis oral  1  4/12 (33.33%)  6 4/10 (40.00%)  4 4/11 (36.36%)  5 5/10 (50.00%)  8 11/29 (37.93%)  28
Nausea  1  6/12 (50.00%)  27 1/10 (10.00%)  2 4/11 (36.36%)  11 5/10 (50.00%)  7 7/29 (24.14%)  24
Oral hemorrhage  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Oral pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 1/29 (3.45%)  1
Proctitis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/29 (0.00%)  0
Stomach pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/29 (0.00%)  0
Vomiting  1  4/12 (33.33%)  9 0/10 (0.00%)  0 2/11 (18.18%)  2 2/10 (20.00%)  2 3/29 (10.34%)  7
General disorders           
Chills  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 2/29 (6.90%)  2
Facial pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  2
Fatigue  1  10/12 (83.33%)  42 6/10 (60.00%)  16 4/11 (36.36%)  12 6/10 (60.00%)  12 13/29 (44.83%)  39
Fever  1  0/12 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  7 0/10 (0.00%)  0 2/29 (6.90%)  2
Flu like symptoms  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Localized edema  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Malaise  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Non-cardiac chest pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  3 0/29 (0.00%)  0
Pain  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 1/10 (10.00%)  1 2/29 (6.90%)  2
Infections and infestations           
Urinary tract infection  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Injury, poisoning and procedural complications           
Bruising  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Investigations           
Alanine aminotransferase increased  1  0/12 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  3 2/10 (20.00%)  3 2/29 (6.90%)  2
Alkaline phosphatase increased  1  0/12 (0.00%)  0 2/10 (20.00%)  2 1/11 (9.09%)  4 2/10 (20.00%)  2 4/29 (13.79%)  6
Aspartate aminotransferase increased  1  0/12 (0.00%)  0 1/10 (10.00%)  1 0/11 (0.00%)  0 2/10 (20.00%)  2 4/29 (13.79%)  5
Blood bilirubin increased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  5
CD4 lymphocytes decreased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Creatinine increased  1  0/12 (0.00%)  0 1/10 (10.00%)  2 0/11 (0.00%)  0 2/10 (20.00%)  3 0/29 (0.00%)  0
INR increased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Lymphocyte count decreased  1  4/12 (33.33%)  11 4/10 (40.00%)  4 2/11 (18.18%)  22 4/10 (40.00%)  5 7/29 (24.14%)  23
Neutrophil count decreased  1  6/12 (50.00%)  26 5/10 (50.00%)  9 8/11 (72.73%)  20 5/10 (50.00%)  7 17/29 (58.62%)  41
Platelet count decreased  1  5/12 (41.67%)  29 5/10 (50.00%)  15 6/11 (54.55%)  19 3/10 (30.00%)  5 14/29 (48.28%)  66
Serum amylase increased  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Weight loss  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
White blood cell decreased  1  7/12 (58.33%)  35 4/10 (40.00%)  6 6/11 (54.55%)  38 6/10 (60.00%)  9 12/29 (41.38%)  45
Metabolism and nutrition disorders           
Anorexia  1  1/12 (8.33%)  2 1/10 (10.00%)  2 2/11 (18.18%)  8 2/10 (20.00%)  2 4/29 (13.79%)  21
Dehydration  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Hypercalcemia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 0/10 (0.00%)  0 0/29 (0.00%)  0
Hyperglycemia  1  1/12 (8.33%)  1 1/10 (10.00%)  2 3/11 (27.27%)  12 3/10 (30.00%)  7 2/29 (6.90%)  5
Hyperkalemia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Hypoalbuminemia  1  2/12 (16.67%)  2 1/10 (10.00%)  1 3/11 (27.27%)  11 1/10 (10.00%)  1 0/29 (0.00%)  0
Hypocalcemia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  3
Hypokalemia  1  2/12 (16.67%)  2 0/10 (0.00%)  0 2/11 (18.18%)  3 0/10 (0.00%)  0 2/29 (6.90%)  2
Hyponatremia  1  2/12 (16.67%)  2 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 4/29 (13.79%)  6
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Back pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 2/29 (6.90%)  2
Bone pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  3
Chest wall pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Head soft tissue necrosis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Muscle weakness right-sided  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorder - Other, specify  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  7
Myalgia  1  0/12 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 1/29 (3.45%)  1
Neck pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/29 (0.00%)  0
Pain in extremity  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Tumor pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 0/10 (0.00%)  0 0/29 (0.00%)  0
Nervous system disorders           
Amnesia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  3
Ataxia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  2
Dizziness  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 1/10 (10.00%)  1 1/29 (3.45%)  2
Dysgeusia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Headache  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  3 1/29 (3.45%)  1
Lethargy  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Peripheral sensory neuropathy  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 2/10 (20.00%)  3 3/29 (10.34%)  7
Seizure  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 0/29 (0.00%)  0
Somnolence  1  0/12 (0.00%)  0 1/10 (10.00%)  2 3/11 (27.27%)  6 4/10 (40.00%)  6 7/29 (24.14%)  15
Syncope  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Psychiatric disorders           
Anxiety  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/29 (3.45%)  1
Confusion  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 2/29 (6.90%)  3
Depression  1  0/12 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  2 1/10 (10.00%)  1 1/29 (3.45%)  1
Hallucinations  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Insomnia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 0/10 (0.00%)  0 1/29 (3.45%)  3
Libido decreased  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  4 0/29 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Hematuria  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  3 0/29 (0.00%)  0
Proteinuria  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Urinary frequency  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  5 0/29 (0.00%)  0
Urinary incontinence  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  2
Urinary tract obstruction  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 0/29 (0.00%)  0
Urinary tract pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/29 (0.00%)  0
Urinary urgency  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 1/10 (10.00%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Allergic rhinitis  1  1/12 (8.33%)  4 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Cough  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  4 1/10 (10.00%)  4 3/29 (10.34%)  11
Dyspnea  1  0/12 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  6 1/10 (10.00%)  5 2/29 (6.90%)  5
Epistaxis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Hypoxia  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Nasal congestion  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Pharyngolaryngeal pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  2
Pleural hemorrhage  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Productive cough  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders - Other, specify  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  4
Sleep apnea  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/29 (0.00%)  0
Sneezing  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Skin and subcutaneous tissue disorders           
Alopecia  1  7/12 (58.33%)  37 4/10 (40.00%)  19 8/11 (72.73%)  44 8/10 (80.00%)  24 17/29 (58.62%)  79
Dry skin  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  3
Hyperhidrosis  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  2 0/10 (0.00%)  0 0/29 (0.00%)  0
Nail loss  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Nail ridging  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  5
Palmar-plantar erythrodysesthesia syndrome  1  3/12 (25.00%)  10 0/10 (0.00%)  0 1/11 (9.09%)  3 1/10 (10.00%)  2 0/29 (0.00%)  0
Pruritus  1  1/12 (8.33%)  1 1/10 (10.00%)  1 1/11 (9.09%)  1 2/10 (20.00%)  3 4/29 (13.79%)  13
Rash acneiform  1  0/12 (0.00%)  0 1/10 (10.00%)  1 1/11 (9.09%)  22 0/10 (0.00%)  0 1/29 (3.45%)  1
Rash maculo-papular  1  3/12 (25.00%)  4 1/10 (10.00%)  2 1/11 (9.09%)  1 0/10 (0.00%)  0 1/29 (3.45%)  1
Scalp pain  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  3 0/10 (0.00%)  0 0/29 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1  0/12 (0.00%)  0 0/10 (0.00%)  0 1/11 (9.09%)  1 0/10 (0.00%)  0 1/29 (3.45%)  2
Skin hyperpigmentation  1  1/12 (8.33%)  5 0/10 (0.00%)  0 1/11 (9.09%)  4 0/10 (0.00%)  0 1/29 (3.45%)  2
Vascular disorders           
Hot flashes  1  1/12 (8.33%)  4 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  2 0/29 (0.00%)  0
Hypertension  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 1/10 (10.00%)  1 1/29 (3.45%)  4
Thromboembolic event  1  1/12 (8.33%)  1 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 0/29 (0.00%)  0
Vascular disorders - Other, specify  1  0/12 (0.00%)  0 0/10 (0.00%)  0 0/11 (0.00%)  0 0/10 (0.00%)  0 1/29 (3.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Mark Andrew Dickson M.D.
Organization: Memorial Sloan Kettering Cancer Center
Phone: 6468884164
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01653028     History of Changes
Other Study ID Numbers: NCI-2012-01991
NCI-2012-01991 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000737403
A091102
CALGB-A091102
A091102 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091102 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: July 26, 2012
First Posted: July 30, 2012
Results First Submitted: August 22, 2016
Results First Posted: December 28, 2016
Last Update Posted: November 30, 2017