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Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01449370
First received: August 11, 2011
Last updated: January 13, 2017
Last verified: January 2017
Results First Received: January 13, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Solid Tumors
Intervention: Drug: TAK-117

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 5 investigative sites in England, Spain and the United States from 06 October 2011 to 15 January 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with advanced solid tumors were enrolled in dose escalation phase to receive TAK-117(MLN1117) in 1 of 4 treatment regimen.Study originally used clinical trial material(CTM) in Process A and new CTM in Process B. Due to limited single-agent TAK-117 activity in dose escalation phase,Study was terminated before start of planned expansion.

Reporting Groups
  Description
Process A: TAK-117 100 Milligram (mg), Once Daily (QD) TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 150 mg, QD TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 200 mg, QD TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 300 mg, QD TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 200 mg, MWF QW TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 300 mg, MWF QW TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 400 mg, MWF QW TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 600 mg, MWF QW TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 900 mg, MWF QW TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 1200 mg, MWF QW TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 200 mg, MTW QW TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 400 mg, MTW QW TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 600 mg, MTW QW TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 900 mg, MTW QW TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 900 mg FM MWF QW TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1200 mg FM MWF QW TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 600 mg FM MTW QW TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 900 mg FM MTW QW TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1200 mg FM MTW QW TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1500 mg FM MTW QW TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 400 mg FM BID MWF QW TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 500 mg FM BID MWF QW TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 600 mg FM BID MWF QW TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.

Participant Flow:   Overall Study
    Process A: TAK-117 100 Milligram (mg), Once Daily (QD)   Process A: TAK-117 150 mg, QD   Process A: TAK-117 200 mg, QD   Process A: TAK-117 300 mg, QD   Process A: TAK-117 200 mg, MWF QW   Process A: TAK-117 300 mg, MWF QW   Process A: TAK-117 400 mg, MWF QW   Process A: TAK-117 600 mg, MWF QW   Process A: TAK-117 900 mg, MWF QW   Process A: TAK-117 1200 mg, MWF QW   Process A: TAK-117 200 mg, MTW QW   Process A: TAK-117 400 mg, MTW QW   Process A: TAK-117 600 mg, MTW QW   Process A: TAK-117 900 mg, MTW QW   Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW   Process B: TAK-117 900 mg FM MWF QW   Process B: TAK-117 1200 mg FM MWF QW   Process B: TAK-117 600 mg FM MTW QW   Process B: TAK-117 900 mg FM MTW QW   Process B: TAK-117 1200 mg FM MTW QW   Process B: TAK-117 1500 mg FM MTW QW   Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW   Process B: TAK-117 400 mg FM BID MWF QW   Process B: TAK-117 500 mg FM BID MWF QW   Process B: TAK-117 600 mg FM BID MWF QW
STARTED   6   6   8   4   3   3   3   3   12   3   3   3   3   11   3   3   7   3   3   3   6   4   4   10   8 
COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0 
NOT COMPLETED   6   6   8   4   3   3   3   3   12   3   3   3   3   11   3   3   7   3   3   3   6   4   4   10   8 
Disease Progression                5                4                8                3                3                3                3                2                9                1                3                3                2                8                3                1                4                3                1                2                5                2                3                7                3 
Adverse Event                1                2                0                1                0                0                0                0                1                1                0                0                0                2                0                1                0                0                1                1                0                1                0                1                3 
Participant Decision                0                0                0                0                0                0                0                1                1                0                0                0                1                1                0                1                3                0                1                0                0                1                0                0                1 
Lost to Follow-up                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                1                0                0                0                0 
Other                0                0                0                0                0                0                0                0                1                1                0                0                0                0                0                0                0                0                0                0                0                0                1                1                0 
Medication Prohibited by Protocol                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                1                0 
Death                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The all subjects as treated (ASaT) population included all enrolled participants who received at least 1 dose of TAK-117.

Reporting Groups
  Description
Process A: TAK-117 100 Milligram (mg), Once Daily (QD) TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 150 mg, QD TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 200 mg, QD TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 300 mg, QD TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
Process A: TAK-117 200 mg, MWF QW TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 300 mg, MWF QW TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 400 mg, MWF QW TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 600 mg, MWF QW TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 900 mg, MWF QW TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 1200 mg, MWF QW TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 200 mg, MTW QW TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 400 mg, MTW QW TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 600 mg, MTW QW TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process A: TAK-117 900 mg, MTW QW TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 900 mg FM MWF QW TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1200 mg FM MWF QW TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 600 mg FM MTW QW TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 900 mg FM MTW QW TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1200 mg FM MTW QW TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 1500 mg FM MTW QW TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 400 mg FM BID MWF QW TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 500 mg FM BID MWF QW TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Process B: TAK-117 600 mg FM BID MWF QW TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
Total Total of all reporting groups

Baseline Measures
   Process A: TAK-117 100 Milligram (mg), Once Daily (QD)   Process A: TAK-117 150 mg, QD   Process A: TAK-117 200 mg, QD   Process A: TAK-117 300 mg, QD   Process A: TAK-117 200 mg, MWF QW   Process A: TAK-117 300 mg, MWF QW   Process A: TAK-117 400 mg, MWF QW   Process A: TAK-117 600 mg, MWF QW   Process A: TAK-117 900 mg, MWF QW   Process A: TAK-117 1200 mg, MWF QW   Process A: TAK-117 200 mg, MTW QW   Process A: TAK-117 400 mg, MTW QW   Process A: TAK-117 600 mg, MTW QW   Process A: TAK-117 900 mg, MTW QW   Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW   Process B: TAK-117 900 mg FM MWF QW   Process B: TAK-117 1200 mg FM MWF QW   Process B: TAK-117 600 mg FM MTW QW   Process B: TAK-117 900 mg FM MTW QW   Process B: TAK-117 1200 mg FM MTW QW   Process B: TAK-117 1500 mg FM MTW QW   Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW   Process B: TAK-117 400 mg FM BID MWF QW   Process B: TAK-117 500 mg FM BID MWF QW   Process B: TAK-117 600 mg FM BID MWF QW   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   8   4   3   3   3   3   12   3   3   3   3   11   3   3   7   3   3   3   6   4   4   10   8   125 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.7  (9.79)   59.0  (10.88)   59.3  (9.05)   45.3  (7.27)   56.3  (17.67)   52.7  (14.01)   54.3  (12.58)   65.0  (13.11)   56.4  (13.28)   53.3  (19.40)   64.7  (18.58)   50.0  (11.53)   55.0  (9.54)   57.4  (10.88)   65.7  (12.86)   62.7  (16.17)   61.0  (11.89)   52.7  (19.76)   53.7  (1.53)   66.7  (2.52)   61.3  (13.68)   72.5  (4.65)   60.3  (11.81)   66.0  (8.71)   59.5  (10.39)   59.4  (11.89) 
Gender 
[Units: Participants]
Count of Participants
                                                   
Female      4  66.7%      4  66.7%      5  62.5%      3  75.0%      2  66.7%      2  66.7%      2  66.7%      3 100.0%      9  75.0%      3 100.0%      1  33.3%      1  33.3%      3 100.0%      7  63.6%      1  33.3%      1  33.3%      5  71.4%      1  33.3%      2  66.7%      2  66.7%      4  66.7%      4 100.0%      4 100.0%      5  50.0%      6  75.0%      84  67.2% 
Male      2  33.3%      2  33.3%      3  37.5%      1  25.0%      1  33.3%      1  33.3%      1  33.3%      0   0.0%      3  25.0%      0   0.0%      2  66.7%      2  66.7%      0   0.0%      4  36.4%      2  66.7%      2  66.7%      2  28.6%      2  66.7%      1  33.3%      1  33.3%      2  33.3%      0   0.0%      0   0.0%      5  50.0%      2  25.0%      41  32.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
                                                   
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  10.0%      1  12.5%      2   1.6% 
Not Hispanic or Latino      5  83.3%      6 100.0%      6  75.0%      4 100.0%      3 100.0%      3 100.0%      2  66.7%      3 100.0%      11  91.7%      3 100.0%      3 100.0%      2  66.7%      3 100.0%      11 100.0%      3 100.0%      3 100.0%      7 100.0%      3 100.0%      3 100.0%      3 100.0%      6 100.0%      4 100.0%      4 100.0%      9  90.0%      7  87.5%      117  93.6% 
Unknown or Not Reported      1  16.7%      0   0.0%      2  25.0%      0   0.0%      0   0.0%      0   0.0%      1  33.3%      0   0.0%      1   8.3%      0   0.0%      0   0.0%      1  33.3%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      6   4.8% 
Race/Ethnicity, Customized 
[Units: Participants]
                                                   
White   6   6   8   3   3   2   1   3   12   3   3   1   3   11   2   2   7   3   3   3   6   3   3   10   8   115 
Black or African American   0   0   0   0   0   1   0   0   0   0   0   1   0   0   0   1   0   0   0   0   0   0   1   0   0   4 
Asian   0   0   0   1   0   0   1   0   0   0   0   1   0   0   0   0   0   0   0   0   0   0   0   0   0   3 
Other   0   0   0   0   0   0   0   0   0   0   0   0   0   0   1   0   0   0   0   0   0   1   0   0   0   2 
Not Reported   0   0   0   0   0   0   1   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   1 
Female Child Bearing Potential 
[Units: Participants]
                                                   
Females of Child-bearing Potential   0   0   1   1   1   0   0   0   1   0   0   1   0   0   0   0   0   0   0   0   0   0   1   1   0   7 
Post-menopausal   4   3   3   0   1   1   1   1   4   2   0   0   2   2   0   1   4   1   2   1   4   4   3   3   4   51 
Sterilized Females   0   1   1   2   0   1   1   2   4   1   1   0   1   5   1   0   1   0   0   1   0   0   0   1   2   26 
Males (Excluded from this analysis)   2   2   3   1   1   1   1   0   3   0   2   2   0   4   2   2   2   2   1   1   2   0   0   5   2   41 
Height [1] 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 161.70  (10.758)   164.29  (7.241)   165.25  (9.403)   164.15  (5.837)   164.19  (5.195)   161.81  (5.222)   165.17  (7.848)   163.49  (6.883)   163.08  (12.871)   158.76  (9.161)   168.76  (2.043)   173.43  (6.072)   164.67  (3.055)   167.46  (10.274)   170.22  (1.683)   168.93  (16.176)   168.32  (4.243)   169.83  (13.829)   169.52  (8.713)   168.11  (6.887)   165.97  (6.472)   159.00  (3.939)   157.05  (3.316)   168.79  (13.186)   164.87  (9.638)   165.49  (9.098) 
[1] Height data was available only for 119 participants as follow: n=5,6,8,2,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,9,7.
Weight [1] 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 62.18  (6.403)   71.15  (21.862)   73.48  (9.159)   67.65  (24.513)   72.48  (17.665)   61.54  (2.487)   57.73  (0.462)   63.41  (3.880)   69.14  (15.486)   65.03  (15.137)   70.76  (16.458)   83.39  (28.852)   60.60  (9.016)   73.78  (12.955)   72.26  (11.235)   75.22  (12.679)   79.84  (16.648)   81.07  (25.417)   82.72  (17.982)   62.61  (15.706)   64.59  (16.477)   73.65  (16.747)   65.37  (11.853)   70.51  (15.263)   65.11  (9.599)   70.17  (14.958) 
[1] Weight data was available only for 123 participants as follow: n=5,6,8,4,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,10,8.
Body Surface Area (BSA) [1] 
[Units: Square meter (m^2)]
Mean (Standard Deviation)
 1.67  (0.108)   1.78  (0.266)   1.83  (0.152)   1.85  (0.500)   1.81  (0.241)   1.66  (0.060)   1.63  (0.041)   1.70  (0.063)   1.76  (0.248)   1.69  (0.192)   1.81  (0.209)   1.99  (0.354)   1.66  (0.110)   1.85  (0.214)   1.85  (0.151)   1.88  (0.235)   1.92  (0.210)   1.95  (0.384)   1.97  (0.262)   1.70  (0.250)   1.72  (0.253)   1.80  (0.217)   1.68  (0.154)   1.82  (0.256)   1.71  (0.170)   1.79  (0.219) 
[1] BSA data was available only for 119 participants as follow: n=5,6,8,2,3,2,3,3,12,3,3,3,3,11,3,3,7,3,3,3,6,4,4,9,7.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of TAK-117   [ Time Frame: Baseline up to Cycle 1 Day 21 ]

2.  Primary:   Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1   [ Time Frame: Baseline up to Cycle 27 Day 45 ]

3.  Primary:   Number of Participants With Highest Level of TEAEs Severity   [ Time Frame: Baseline up to Cycle 27 Day 45 ]

4.  Primary:   Number of Participants With Clinically Meaningful Changes in Laboratory Values   [ Time Frame: Baseline up to Cycle 27 Day 45 ]

5.  Primary:   Number of Participants With Clinically Meaningful Changes in Vital Signs   [ Time Frame: Baseline up to Cycle 27 day 45 ]

6.  Primary:   Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)   [ Time Frame: Baseline up to Cycle 27 Day 45 ]

7.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death ]

8.  Secondary:   Duration of Objective Response   [ Time Frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death ]

9.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death ]

10.  Secondary:   Cmax: Maximum Observed Plasma Concentration for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

11.  Secondary:   Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

12.  Secondary:   Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

13.  Secondary:   T 1/2z: Terminal Disposition Phase Half-life for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

14.  Secondary:   AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

15.  Secondary:   AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

16.  Secondary:   %AUC Extrapolated: Percentage of Area Under Concentration-extrapolated   [ Time Frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose ]

17.  Secondary:   Percent Change From Baseline in Pharmacodynamic Markers   [ Time Frame: Cycle 1 Day 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: trialdisclosures@takeda.com



Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01449370     History of Changes
Other Study ID Numbers: INK1117-001
Study First Received: August 11, 2011
Results First Received: January 13, 2017
Last Updated: January 13, 2017