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Trial record 16 of 59 for:    MLN8237

MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

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: NCT00853307
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Carcinoma
Intervention Drug: Alisertib
Enrollment 31
Recruitment Details Participants took part in the study at 17 investigative sites in France, Poland and the United States from 23 March 2009 to 27 January 2011.
Pre-assignment Details Participants with a diagnosis of Platinum-refractory and Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma received 50 mg alisertib twice daily for 7 days in 21-day cycles.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Period Title: Overall Study
Started 6 25
Completed 4 [1] 20
Not Completed 2 5
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             1             2
Reason Not Specified             0             1
[1]
Completed = participants who completed the study treatment.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant) Total
Hide Arm/Group Description Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen. Total of all reporting groups
Overall Number of Baseline Participants 6 25 31
Hide Baseline Analysis Population Description
Safety Population is defined as all participants who receive any amount of alisertib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 25 participants 31 participants
58.3  (15.38) 56.6  (14.19) 57.0  (14.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 31 participants
Female
6
 100.0%
25
 100.0%
31
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 31 participants
White 6 24 30
Asian 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 31 participants
Hispanic or Latino 1 1 2
Not Hispanic or Latino 3 22 25
Not Reported 2 2 4
Primary diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 31 participants
Epithelial Ovarian 5 20 25
Fallopian Tube 0 1 1
Primary Peritoneal Carcinoma 1 4 5
Years Since Initial Diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 25 participants 31 participants
1.59  (0.736) 2.26  (1.448) 2.13  (1.356)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 25 participants 31 participants
ECOG Performance Status = 0 2 18 20
ECOG Performance Status = 1 4 7 11
[1]
Measure Description: ECOG performance is defined as: 0=Normal activity (fully active, able to carry on all predisease performance without restriction); 1=Symptoms but ambulatory (restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature); 2=In bed <50% of the time (ambulatory and capable of all self-care, but unable to carry out any work activities); 3=In bed >50% of the time (capable of only limited self-care); 4=100% bedridden (completely disabled, cannot carry on any selfcare, totally confined to bed or chair).
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 6 participants 25 participants 31 participants
162.0  (4.83) 160.9  (7.76) 161.0  (7.34)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 6 participants 25 participants 31 participants
65.16  (9.638) 68.22  (17.227) 67.63  (15.951)
Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Meter (m)^2
Number Analyzed 6 participants 25 participants 31 participants
1.72  (0.167) 1.72  (0.223) 1.72  (0.212)
[1]
Measure Description: Body Surface Area = square root [height (cm)*weight (kg) / 3600 ].
1.Primary Outcome
Title Combined Best Overall Response Rate Based on Investigator Assessment
Hide Description Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of > 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).
Time Frame Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/milliliter (mL) and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Measure Type: Number
Unit of Measure: percentage of participants
0 12
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS is defined as the time in days from the date of first study drug administration to the date of first documented Progressive Disease (PD) or death. PD is defined as 20% increase in the sum of the longest diameter of target lesions. CA 125 progression for participants with normal CA 125 levels is defined as a CA 125 level > 2 times the upper limit of normal and for participants with elevated values during the trial, is defined as a CA 125 level greater than 2 times the nadir value of CA 125. For a participant who has not progressed and has not died, PFS is censored at the last response assessment that is stable disease (SD) or better.
Time Frame Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is defined as all participants who have measurable neoplastic disease according to RECIST criteria OR participants with CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and received at least 1 dose of alisertib and have at least 1 post-baseline response assessment.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Median (95% Confidence Interval)
Unit of Measure: days
36.5
(23.0 to 120.0)
77.0
(43.0 to 122.0)
3.Secondary Outcome
Title Duration Of Response (DOR)
Hide Description DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.
Time Frame Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, there was insufficient data to perform this analysis.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time To Progression (TTP)
Hide Description TTP is defined as the time in days from the date of first study drug administration to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions.
Time Frame Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Due to study termination, there was insufficient data to perform this analysis.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Clinical Benefit Rate
Hide Description Clinical benefit rate is defined as the percentage of participants with response and stable disease (SD), where in order for SD to qualify as having clinical benefit, there must be no progression of neoplastic disease for at least 4 treatment cycles.
Time Frame Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population is defined as all participants who have measurable neoplastic disease according to the RECIST criteria OR participants with a CA 125 level > 40 units/mL and clinical evidence of neoplastic disease and receive at least 1 dose of alisertib and have at least 1 post-baseline response assessment
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Measure Type: Number
Unit of Measure: percentage of participants
0 32
6.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame First dose to 30 days past last dose (Up to 18.9 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Measure Type: Number
Unit of Measure: participants
AE 6 24
SAE 4 7
7.Secondary Outcome
Title Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events
Hide Description Vital signs included blood pressure, pulse rate, and oral temperature collected throughout the study. . A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame Baseline, Cycle 1 Days 8 and 15, then Day 1 of every cycle (21 days), End of Treatment, End of Study/FU every 12 weeks for up to 12 months (Up to 22 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Measure Type: Number
Unit of Measure: participants
Pyrexia 2 6
Dyspnoea 0 4
Weight decreased 0 3
Tachycardia 0 2
Hypertension 0 2
Dyspnoea exertional 0 1
Bradycardia 0 1
Shock 1 0
8.Secondary Outcome
Title Number of Participants With Abnormal Laboratory Values Reported as Treatment-Emergent Adverse Events
Hide Description Laboratory tests included Hematology and Chemistry. Abnormal laboratory value were assessed as an AE if the value leads to discontinuation or delay in treatment, dose modification, therapeutic intervention, or is considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time Frame Baseline, Cycle 1 Days 8 and 15, then Every cycle Days 1, 8 and 15 to End of Treatment Up to 18.0 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population is defined as all participants who received any amount of alisertib.
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description:
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy.
Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
Overall Number of Participants Analyzed 6 25
Measure Type: Number
Unit of Measure: participants
Neutropenia 3 17
Anaemia 2 14
Leukopenia 1 11
Thrombocytopenia 1 8
Dehydration 1 7
Hypokalaemia 2 4
Alanine aminotransferase increased 0 6
Aspartate aminotransferase increased 0 6
Hyperglycaemia 1 4
Hypomagnesaemia 1 4
Blood alkaline phosphatase increased 1 4
Febrile neutropenia 0 3
Hyponatraemia 1 2
Haemoglobin decreased 1 2
Granulocytopenia 0 2
Neutrophil count increased 0 2
White blood cell count increased 0 2
Hyperbilirubinaemia 1 1
Lymphopenia 1 0
Hyperkalaemia 0 1
Hypernatraemia 0 1
Hypercholesterolaemia 0 1
Transaminases increased 1 0
Granulocyte count decreased 0 1
Blood calcium increased 0 1
Blood magnesium decreased 0 1
Platelet count decreased 1 0
Blood albumin decreased 0 1
Creatinine renal clearance decreased 0 1
Hypoxia 0 1
Bacteraemia 1 0
Time Frame First dose of study drug to 30 past last dose of study drug (Up to18.9 Months)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Hide Arm/Group Description Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).Platinum-refractory disease is characterized by a lack of response, progression, or recurrence of disease during a course of platinum-based therapy. Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles). Platinum-resistant disease is characterized by progression or recurrence of malignant disease within 6 months after completion of a platinum-based regimen.
All-Cause Mortality
Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   7/25 (28.00%) 
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/6 (0.00%)  3/25 (12.00%) 
Neutropenia  1  1/6 (16.67%)  1/25 (4.00%) 
Anaemia  1  1/6 (16.67%)  1/25 (4.00%) 
Leukopenia  1  1/6 (16.67%)  1/25 (4.00%) 
Thrombocytopenia  1  0/6 (0.00%)  1/25 (4.00%) 
Gastrointestinal disorders     
Stomatitis  1  1/6 (16.67%)  1/25 (4.00%) 
Abdominal pain  1  1/6 (16.67%)  1/25 (4.00%) 
Abdominal mass  1  0/6 (0.00%)  1/25 (4.00%) 
Small intestinal obstruction  1  1/6 (16.67%)  1/25 (4.00%) 
Intestinal obstruction  1  1/6 (16.67%)  0/25 (0.00%) 
Vomiting  1  1/6 (16.67%)  0/25 (0.00%) 
General disorders     
Pyrexia  1  1/6 (16.67%)  2/25 (8.00%) 
Infections and infestations     
Clostridium colitis  1  0/6 (0.00%)  1/25 (4.00%) 
Bacteraemia  1  1/6 (16.67%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  1/6 (16.67%)  0/25 (0.00%) 
Dehydration  1  0/6 (0.00%)  1/25 (4.00%) 
Nervous system disorders     
Hypoaesthesia  1  0/6 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  0/6 (0.00%)  1/25 (4.00%) 
Vascular disorders     
Shock  1  1/6 (16.67%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alisertib 50 mg (Platinum-Refractory) Alisertib 50 mg (Platinum-Resistant)
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   24/25 (96.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  3/6 (50.00%)  16/25 (64.00%) 
Anaemia  1  1/6 (16.67%)  13/25 (52.00%) 
Leukopenia  1  1/6 (16.67%)  11/25 (44.00%) 
Thrombocytopenia  1  1/6 (16.67%)  7/25 (28.00%) 
Granulocytopenia  1  0/6 (0.00%)  2/25 (8.00%) 
Lymphopenia  1  1/6 (16.67%)  0/25 (0.00%) 
Cardiac disorders     
Tachycardia  1  0/6 (0.00%)  2/25 (8.00%) 
Eye disorders     
Vision blurred  1  1/6 (16.67%)  1/25 (4.00%) 
Gastrointestinal disorders     
Diarrhoea  1  3/6 (50.00%)  14/25 (56.00%) 
Stomatitis  1  2/6 (33.33%)  13/25 (52.00%) 
Nausea  1  3/6 (50.00%)  11/25 (44.00%) 
Vomiting  1  4/6 (66.67%)  8/25 (32.00%) 
Abdominal pain  1  2/6 (33.33%)  8/25 (32.00%) 
Constipation  1  1/6 (16.67%)  4/25 (16.00%) 
Ascites  1  1/6 (16.67%)  2/25 (8.00%) 
Flatulence  1  1/6 (16.67%)  2/25 (8.00%) 
Abdominal distension  1  0/6 (0.00%)  2/25 (8.00%) 
Abdominal pain upper  1  0/6 (0.00%)  2/25 (8.00%) 
Dysphagia  1  0/6 (0.00%)  2/25 (8.00%) 
Gingival bleeding  1  0/6 (0.00%)  2/25 (8.00%) 
Abdominal rigidity  1  1/6 (16.67%)  0/25 (0.00%) 
Gastritis  1  1/6 (16.67%)  0/25 (0.00%) 
General disorders     
Fatigue  1  3/6 (50.00%)  15/25 (60.00%) 
Pyrexia  1  1/6 (16.67%)  5/25 (20.00%) 
Asthenia  1  0/6 (0.00%)  3/25 (12.00%) 
Chills  1  1/6 (16.67%)  2/25 (8.00%) 
Oedema peripheral  1  0/6 (0.00%)  3/25 (12.00%) 
Early satiety  1  1/6 (16.67%)  1/25 (4.00%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  1/6 (16.67%)  1/25 (4.00%) 
Infections and infestations     
Urinary tract infection  1  1/6 (16.67%)  3/25 (12.00%) 
Sinusitis  1  0/6 (0.00%)  2/25 (8.00%) 
Upper respiratory tract infection  1  0/6 (0.00%)  2/25 (8.00%) 
Investigations     
Alanine aminotransferase increased  1  0/6 (0.00%)  6/25 (24.00%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  6/25 (24.00%) 
Blood alkaline phosphatase increased  1  1/6 (16.67%)  4/25 (16.00%) 
Haemoglobin decreased  1  1/6 (16.67%)  2/25 (8.00%) 
Weight decreased  1  0/6 (0.00%)  3/25 (12.00%) 
Neutrophil count increased  1  0/6 (0.00%)  2/25 (8.00%) 
White blood cell count increased  1  0/6 (0.00%)  2/25 (8.00%) 
Platelet count decreased  1  1/6 (16.67%)  0/25 (0.00%) 
Transaminases increased  1  1/6 (16.67%)  0/25 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/6 (0.00%)  7/25 (28.00%) 
Dehydration  1  1/6 (16.67%)  6/25 (24.00%) 
Hyperglycaemia  1  1/6 (16.67%)  4/25 (16.00%) 
Hypokalaemia  1  1/6 (16.67%)  4/25 (16.00%) 
Hypomagnesaemia  1  1/6 (16.67%)  4/25 (16.00%) 
Hyponatraemia  1  1/6 (16.67%)  2/25 (8.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/6 (16.67%)  3/25 (12.00%) 
Arthralgia  1  0/6 (0.00%)  2/25 (8.00%) 
Bone pain  1  0/6 (0.00%)  2/25 (8.00%) 
Pain in extremity  1  0/6 (0.00%)  2/25 (8.00%) 
Shoulder pain  1  0/6 (0.00%)  2/25 (8.00%) 
Musculoskeletal pain  1  1/6 (16.67%)  0/25 (0.00%) 
Musculoskeletal stiffness  1  1/6 (16.67%)  0/25 (0.00%) 
Nervous system disorders     
Headache  1  1/6 (16.67%)  5/25 (20.00%) 
Somnolence  1  0/6 (0.00%)  4/25 (16.00%) 
Dizziness  1  0/6 (0.00%)  2/25 (8.00%) 
Dysgeusia  1  0/6 (0.00%)  2/25 (8.00%) 
Depressed level of consciousness  1  1/6 (16.67%)  0/25 (0.00%) 
Psychiatric disorders     
Depression  1  0/6 (0.00%)  2/25 (8.00%) 
Insomnia  1  1/6 (16.67%)  1/25 (4.00%) 
Renal and urinary disorders     
Bladder spasm  1  1/6 (16.67%)  0/25 (0.00%) 
Renal failure acute  1  1/6 (16.67%)  0/25 (0.00%) 
Ureteric obstruction  1  1/6 (16.67%)  0/25 (0.00%) 
Reproductive system and breast disorders     
Vaginal haemorrhage  1  0/6 (0.00%)  2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/6 (0.00%)  4/25 (16.00%) 
Dyspnoea  1  0/6 (0.00%)  4/25 (16.00%) 
Pharyngolaryngeal pain  1  0/6 (0.00%)  4/25 (16.00%) 
Rhinitis allergic  1  0/6 (0.00%)  2/25 (8.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  1/6 (16.67%)  14/25 (56.00%) 
Dry skin  1  0/6 (0.00%)  5/25 (20.00%) 
Pruritus  1  0/6 (0.00%)  4/25 (16.00%) 
Rash pruritic  1  0/6 (0.00%)  4/25 (16.00%) 
Erythema  1  1/6 (16.67%)  2/25 (8.00%) 
Hyperhidrosis  1  0/6 (0.00%)  2/25 (8.00%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/6 (0.00%)  2/25 (8.00%) 
Vascular disorders     
Hypertension  1  0/6 (0.00%)  2/25 (8.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT00853307     History of Changes
Other Study ID Numbers: C14006
2008-006977-34 ( EudraCT Number )
U1111-1187-6616 ( Registry Identifier: WHO )
First Submitted: February 26, 2009
First Posted: March 2, 2009
Results First Submitted: January 4, 2018
Results First Posted: March 27, 2018
Last Update Posted: March 27, 2018