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Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

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: NCT01637961
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : July 17, 2015
Last Update Posted : February 5, 2018
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 Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma
Interventions Drug: Alisertib
Other: Laboratory Biomarker Analysis
Enrollment 23
Recruitment Details The study was activated on 8/6/2012 and closed to accrual on 6/3/2013.
Pre-assignment Details  
Arm/Group Title MLN8237
Hide Arm/Group Description MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Period Title: Overall Study
Started 23
Completed 21 [1]
Not Completed 2
Reason Not Completed
Ineligible: wrong primary             1
Ineligible: inadequate pathology             1
[1]
Eligible and treated patients.
Arm/Group Title MLN8237
Hide Arm/Group Description MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
Eligible and treated patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
60.9  (9.0)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
40-49 years 3
50-59 years 6
60-69 years 9
70-79 years 2
80-89 years 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
21
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
FIGO (International Federation of Gynecology and Obstetrics) Stage - Recurrent/Persistent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
21
Histologic Type - Leiomyosarcoma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants
21
1.Primary Outcome
Title Progression-free Survival (PFS) > 6 Months
Hide Description Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Time Frame Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and Treated Patients
Arm/Group Title MLN8237
Hide Arm/Group Description:
MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 16.1)
2.Primary Outcome
Title Tumor Response
Hide Description Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.
Time Frame Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title MLN8237
Hide Arm/Group Description:
MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 16.1)
3.Secondary Outcome
Title Overall Survival
Hide Description The observed length of life from entry into the study to death or the date of last contact.
Time Frame From study entry to death or last contact, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients.
Arm/Group Title MLN8237
Hide Arm/Group Description:
MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
13.6
(5.65 to 17.28)
4.Secondary Outcome
Title Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0
Hide Description [Not Specified]
Time Frame Every cycle during treatment and 30 days after the last treatment, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Grade 0 Grade 1 (CTCAE v 4.0) Grade 2 (CTCAE v 4.0) Grade 3 (CTCAE v 4.0) Grade 4 (CTCAE v 4.0) Grade 5 (CTCAE v 4.0)
Hide Arm/Group Description:
Number of patients who did not experience the specified AE.
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
Overall Number of Participants Analyzed 21 21 21 21 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
Leukopenia
9
  42.9%
3
  14.3%
4
  19.0%
5
  23.8%
0
   0.0%
0
   0.0%
Thrombocytopenia
11
  52.4%
9
  42.9%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
Neutropenia
11
  52.4%
0
   0.0%
3
  14.3%
5
  23.8%
2
   9.5%
0
   0.0%
Anemia
5
  23.8%
3
  14.3%
9
  42.9%
3
  14.3%
1
   4.8%
0
   0.0%
Other investigations
18
  85.7%
3
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other blood/lymphatics
19
  90.5%
0
   0.0%
0
   0.0%
1
   4.8%
1
   4.8%
0
   0.0%
Cardiac
20
  95.2%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
Nausea
15
  71.4%
3
  14.3%
3
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Vomiting
18
  85.7%
3
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other gastrointestinal
4
  19.0%
7
  33.3%
6
  28.6%
4
  19.0%
0
   0.0%
0
   0.0%
General and administration site
9
  42.9%
5
  23.8%
7
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
Infections/infestations
19
  90.5%
0
   0.0%
2
   9.5%
0
   0.0%
0
   0.0%
0
   0.0%
Metabolism/nutrition
14
  66.7%
1
   4.8%
6
  28.6%
0
   0.0%
0
   0.0%
0
   0.0%
Musculoskeletal/connective tissue
16
  76.2%
3
  14.3%
1
   4.8%
1
   4.8%
0
   0.0%
0
   0.0%
Peripheral sensory neuropathy
20
  95.2%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nervous system
12
  57.1%
5
  23.8%
4
  19.0%
0
   0.0%
0
   0.0%
0
   0.0%
Psychiatric
19
  90.5%
2
   9.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Renal/urinary
19
  90.5%
2
   9.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reproductive/breast
19
  90.5%
1
   4.8%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
Respiratory/thoracic/mediastinal
16
  76.2%
4
  19.0%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
Skin/subcutaneous
7
  33.3%
5
  23.8%
7
  33.3%
2
   9.5%
0
   0.0%
0
   0.0%
Vascular disorders
19
  90.5%
0
   0.0%
1
   4.8%
1
   4.8%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Progression Free Survival
Hide Description Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time Frame every other cycle for the first 6 months; then every 3 months thereafter until disease progression is confirmed; up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title MLN8237
Hide Arm/Group Description:
MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
Overall Number of Participants Analyzed 21
Median (90% Confidence Interval)
Unit of Measure: months
1.7
(1.4 to 3.2)
6.Other Pre-specified Outcome
Title Aurora A Kinase Expression
Hide Description Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).
Time Frame Up to 5 years
Outcome Measure Data Not Reported
Time Frame All Adverse Events (AEs) during treatment (up to 30 days after treatment completion). All Serious Adverse Events (SAEs) up to 30 days after treatment completion and considered to be treatment related between 30 days and 5 years after treatment completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MLN8237
Hide Arm/Group Description MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
All-Cause Mortality
MLN8237
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MLN8237
Affected / at Risk (%)
Total   5/21 (23.81%) 
Blood and lymphatic system disorders   
Anemia * 1  1/21 (4.76%) 
Febrile Neutropenia * 1  1/21 (4.76%) 
Cardiac disorders   
Sinus Tachycardia * 1  1/21 (4.76%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Palmar-Plantar Erythrodysesthesia Syndrome * 1  1/21 (4.76%) 
*
Indicates events were collected by non-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%
MLN8237
Affected / at Risk (%)
Total   21/21 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  15/21 (71.43%) 
Febrile Neutropenia * 1  1/21 (4.76%) 
Gastrointestinal disorders   
Dysphagia * 1  1/21 (4.76%) 
Constipation * 1  7/21 (33.33%) 
Diarrhea * 1  8/21 (38.10%) 
Vomiting * 1  3/21 (14.29%) 
Stomach Pain * 1  1/21 (4.76%) 
Abdominal Pain * 1  2/21 (9.52%) 
Mucositis Oral * 1  9/21 (42.86%) 
Oral Hemorrhage * 1  1/21 (4.76%) 
Oral Pain * 1  1/21 (4.76%) 
Nausea * 1  6/21 (28.57%) 
Gastroesophageal Reflux Disease * 1  3/21 (14.29%) 
Esophagitis * 1  1/21 (4.76%) 
General disorders   
Pain * 1  5/21 (23.81%) 
Localized Edema * 1  1/21 (4.76%) 
Fatigue * 1  13/21 (61.90%) 
Fever * 1  2/21 (9.52%) 
Chills * 1  1/21 (4.76%) 
Infections and infestations   
Mucosal Infection * 1  2/21 (9.52%) 
Vaginal Infection * 1  1/21 (4.76%) 
Investigations   
Weight Loss * 1  1/21 (4.76%) 
Platelet Count Decreased * 1  10/21 (47.62%) 
Neutrophil Count Decreased * 1  10/21 (47.62%) 
White Blood Cell Decreased * 1  12/21 (57.14%) 
Aspartate Aminotransferase Increased * 1  1/21 (4.76%) 
Alanine Aminotransferase Increased * 1  2/21 (9.52%) 
Metabolism and nutrition disorders   
Hypokalemia * 1  2/21 (9.52%) 
Hypoalbuminemia * 1  1/21 (4.76%) 
Anorexia * 1  3/21 (14.29%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  1/21 (4.76%) 
Myalgia * 1  3/21 (14.29%) 
Back Pain * 1  1/21 (4.76%) 
Arthralgia * 1  2/21 (9.52%) 
Nervous system disorders   
Somnolence * 1  5/21 (23.81%) 
Peripheral Sensory Neuropathy * 1  1/21 (4.76%) 
Lethargy * 1  1/21 (4.76%) 
Headache * 1  1/21 (4.76%) 
Dysgeusia * 1  1/21 (4.76%) 
Dizziness * 1  2/21 (9.52%) 
Psychiatric disorders   
Insomnia * 1  1/21 (4.76%) 
Depression * 1  1/21 (4.76%) 
Renal and urinary disorders   
Urinary Tract Pain * 1  1/21 (4.76%) 
Urinary Frequency * 1  1/21 (4.76%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  2/21 (9.52%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia * 1  1/21 (4.76%) 
Hiccups * 1  1/21 (4.76%) 
Dyspnea * 1  2/21 (9.52%) 
Cough * 1  2/21 (9.52%) 
Wheezing * 1  1/21 (4.76%) 
Bronchopulmonary Hemorrhage * 1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  1/21 (4.76%) 
Pruritus * 1  1/21 (4.76%) 
Palmar-Plantar Erythrodysesthesia Syndrome * 1  5/21 (23.81%) 
Rash Maculo-Papular * 1  3/21 (14.29%) 
Dry Skin * 1  1/21 (4.76%) 
Alopecia * 1  7/21 (33.33%) 
Vascular disorders   
Hypotension * 1  1/21 (4.76%) 
Hypertension * 1  1/21 (4.76%) 
Hot Flashes * 1  1/21 (4.76%) 
*
Indicates events were collected by non-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: Angela M. Kuras, Associate Director of Data Management
Organization: NRG Oncology Statistics and Data Management Center - Buffalo
Phone: 716-845-7733
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01637961     History of Changes
Other Study ID Numbers: NCI-2012-01982
NCI-2012-01982 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-0231D
CDR0000736350
GOG-0231D ( Other Identifier: NRG Oncology )
GOG-0231D ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2012
First Posted: July 11, 2012
Results First Submitted: April 29, 2015
Results First Posted: July 17, 2015
Last Update Posted: February 5, 2018