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Extension Trial of Deforolimus (Ridaforolimus, MK-8669) in Participants With Advanced Cancer (MK-8669-038)

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ClinicalTrials.gov Identifier: NCT00836927
Recruitment Status : Active, not recruiting
First Posted : February 4, 2009
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced Cancers
Interventions: Drug: Ridaforolimus Tablet
Drug: Ridaforolimus Intravenous (IV) Infusion

  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 who continued to receive clinical benefit from ridaforolimus, or who were being followed for long-term safety and efficacy under the following prior protocols were eligible for enrollment into this extension study: MK-8669-013, NCT00060645; MK-8669-016, NCT00112372; and MK-8669-028, NCT00704054.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants may have continued ridaforolimus IV infusion at the same dose from the parent trial before being switched to ridaforolimus oral tablet.

Reporting Groups
  Description
Ridaforolimus 10 mg Days 1-5 Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
Ridaforolimus 10 mg Days 1-6 Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
Ridaforolimus 20 mg Days 1-5 Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
Ridaforolimus 30 mg Days 1-5 Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
Ridaforolimus 40 mg Days 1-5 Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.

Participant Flow:   Overall Study
    Ridaforolimus 10 mg Days 1-5   Ridaforolimus 10 mg Days 1-6   Ridaforolimus 20 mg Days 1-5   Ridaforolimus 30 mg Days 1-5   Ridaforolimus 40 mg Days 1-5
STARTED   3   1   1 [1]   1   1 
Completed Dosing Through 03 Apr 2017   0   1 [2]   1 [2]   0   0 
COMPLETED   0   0   0   0   0 
NOT COMPLETED   3   1   1   1   1 
Progressive disease                2                0                0                1                1 
Study drug terminated by sponsor                0                1                1                0                0 
Withdrawal by Subject                1                0                0                0                0 
[1] One participant received ridaforolimus 3 mg IV infusion before being switched to the oral tablet.
[2] Participant continues to receive study drug past the data cut-off date of 03 Apr 2017



  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.
No text entered.

Reporting Groups
  Description
Ridaforolimus 10 mg Days 1-5 Ridaforolimus 10 mg administered orally once daily on Days 1-5 per week.
Ridaforolimus 10 mg Days 1-6 Ridaforolimus 10 mg administered orally once daily on Days 1-6 per week.
Ridaforolimus 20 mg Days 1-5 Ridaforolimus 20 mg administered once daily on Days 1-5 per week.
Ridaforolimus 30 mg Days 1-5 Ridaforolimus 30 mg administered orally once daily on Days 1-5 per week.
Ridaforolimus 40 mg Days 1-5 Ridaforolimus 40 mg administered orally once daily on Days 1-5 per week.
Total Total of all reporting groups

Baseline Measures
   Ridaforolimus 10 mg Days 1-5   Ridaforolimus 10 mg Days 1-6   Ridaforolimus 20 mg Days 1-5   Ridaforolimus 30 mg Days 1-5   Ridaforolimus 40 mg Days 1-5   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   1   1   1   1   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (15.0)   47.0   67.0   53.0   13.0   46.1  (18.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      2  66.7%      1 100.0%      1 100.0%      1 100.0%      1 100.0%      6  85.7% 
Male      1  33.3%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  14.3% 
Race/Ethnicity, Customized 
[Units: Participants]
           
White   3   1   1   1   0   6 
Hispanic or Latino   0   0   0   0   1   1 


  Outcome Measures

1.  Primary:   Number of Participants Who Experienced an Adverse Event   [ Time Frame: Up to approximately 2991 days, including 30 days after the last dose (through data cut-off date of 03 Apr 2017) ]

2.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to approximately 2991 days (through data cut-off date of 03 Apr 2017) ]

5.  Secondary:   Duration of Response (DOR)   [ Time Frame: Up to approximately 2961 days (through data cut-off date of 03 Apr 2017) ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: NCT00836927     History of Changes
Other Study ID Numbers: 8669-038
AP23573-08-901 ( Other Identifier: Ariad Protocol Number )
MK-8669-038 ( Other Identifier: Merck Protocol Number )
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: April 3, 2018
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018