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Study of Safety and Pharmacokinetics of MK-8242 in Participants With Advanced Solid Tumors (P07650)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01463696
First received: October 28, 2011
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: March 23, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Tumors
Intervention: Drug: MK-8242

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-8242 60 mg BID In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 120 mg BID In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 170 mg BID In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 250 mg BID In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 300 mg BID In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 350 mg BID In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 400 mg BID In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 500 mg BID In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.

Participant Flow:   Overall Study
    MK-8242 60 mg BID     MK-8242 120 mg BID     MK-8242 170 mg BID     MK-8242 250 mg BID     MK-8242 300 mg BID     MK-8242 350 mg BID     MK-8242 400 mg BID     MK-8242 500 mg BID  
STARTED     1     6     3     7     3     6     16     6  
Treated     1     6     3     7     3     6     15     6  
COMPLETED     1     4     2     3     2     3     6     2  
NOT COMPLETED     0     2     1     4     1     3     10     4  
Adverse Event                 0                 1                 0                 2                 0                 1                 3                 2  
Lost to Follow-up                 0                 0                 1                 0                 0                 0                 0                 0  
Progressive Disease                 0                 1                 0                 1                 0                 1                 4                 2  
Withdrawal by Subject                 0                 0                 0                 1                 1                 1                 2                 0  
Not Treated                 0                 0                 0                 0                 0                 0                 1                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
MK-8242 60 mg BID In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 120 mg BID In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 170 mg BID In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 250 mg BID In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 300 mg BID In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 350 mg BID In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 400 mg BID In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
MK-8242 500 mg BID In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
Total Total of all reporting groups

Baseline Measures
    MK-8242 60 mg BID     MK-8242 120 mg BID     MK-8242 170 mg BID     MK-8242 250 mg BID     MK-8242 300 mg BID     MK-8242 350 mg BID     MK-8242 400 mg BID     MK-8242 500 mg BID     Total  
Number of Participants  
[units: participants]
  1     6     3     7     3     6     16     6     48  
Age  
[units: Years]
Mean (Standard Deviation)
  47.0 [1]   60.0  (11.0)     68.3  (7.4)     60.3  (11.4)     53.3  (12.3)     58.2  (10.2)     63.9  (10.4)     62.5  (12.8)     61.3  (10.8)  
Gender  
[units: Participants]
                 
Female     0     2     2     3     1     2     6     3     19  
Male     1     4     1     4     2     4     10     3     29  
[1] Only 1 participant in population; no SD calculated.



  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLTs)   [ Time Frame: Cycle 1 (21 days) ]

2.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of MK-8242   [ Time Frame: Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ]

3.  Secondary:   Time to Maximum Plasma Concentration (Tmax) of MK-8242   [ Time Frame: Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ]

4.  Secondary:   Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242   [ Time Frame: Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12 ]

5.  Secondary:   AUC at Time of Last Sample (AUClast) for MK-8242   [ Time Frame: Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01463696     History of Changes
Other Study ID Numbers: P07650
2011-001346-15 ( EudraCT Number )
MK-8242-006 ( Other Identifier: Merck Protocol Number )
Study First Received: October 28, 2011
Results First Received: March 23, 2016
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration