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Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00694356
First received: May 29, 2008
Last updated: March 28, 2017
Last verified: March 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Neoplasm
Intervention: Biological: Dalotuzumab

  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
Dalotuzumab 5 mg/kg Participants receive dalotuzumab 5 mg/kg by intravenous (IV) infusion once each week for up to 1 year or until participant withdraws consent, experiences an adverse event (AE), progressive disease or major protocol violation, has moved or is lost to follow up.
Dalotuzumab 10 mg/kg Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
Dalotuzumab 15 mg/kg/7.5 mg/kg Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.

Participant Flow:   Overall Study
    Dalotuzumab 5 mg/kg   Dalotuzumab 10 mg/kg   Dalotuzumab 15 mg/kg/7.5 mg/kg
STARTED   3   6   6 
COMPLETED   0   0   0 
NOT COMPLETED   3   6   6 
Adverse Event                1                0                0 
Progressive Disease                2                6                6 



  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
Dalotuzumab 5 mg/kg Participants receive dalotuzumab 5 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
Dalotuzumab 10 mg/kg Participants receive dalotuzumab 10 mg/kg by IV infusion once each week for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
Dalotuzumab 15 mg/kg/7.5 mg/kg Participants receive an initial dose of dalotuzumab 15 mg/kg by IV infusion followed by a maintenance dose of dalotuzumab 7.5 mg/kg by IV infusion once every 2 weeks for up to 1 year or until participant withdraws consent, experiences an AE, progressive disease or major protocol violation, has moved or is lost to follow up.
Total Total of all reporting groups

Baseline Measures
   Dalotuzumab 5 mg/kg   Dalotuzumab 10 mg/kg   Dalotuzumab 15 mg/kg/7.5 mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   6   6   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.3  (1.5)   63.5  (3.9)   59.2  (14.2)   62.3  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      2  33.3%      2  33.3%      4  26.7% 
Male      3 100.0%      4  66.7%      4  66.7%      11  73.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)   [ Time Frame: Cycle 1 (Up to 4 weeks) ]

2.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to 30 days after last dose of study treatment (Up to 101 days) ]

3.  Primary:   Number of Participants Who Discontinued Study Treatment Due to an AE   [ Time Frame: Up to 71 days ]

4.  Secondary:   Maximum Plasma Concentration (Cmax) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

5.  Secondary:   Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

6.  Secondary:   Time to Cmax (Tmax) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

7.  Secondary:   Apparent Terminal Half-life (t1/2) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

8.  Secondary:   Clearance (CL) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

9.  Secondary:   Steady State Volume of Distribution (Vss) of Dalotuzumab   [ Time Frame: Pre-dose, 0.5 h after start of infusion, end of infusion, 5, 10, 24, 30, 48 and 96 and 168 h post-dose ]

10.  Secondary:   Number of Participants Who Developed a Human Anti-Humanized Antibody (HAHA) Response to Dalotuzumab   [ Time Frame: Cycle 1: predose on Days 1, 8, 15, and 22; Cycles 2 and 3: predose on Day 1; 4 weeks after last dose of study drug ]


  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: NCT00694356     History of Changes
Other Study ID Numbers: 0646-009
2008_012 ( Other Identifier: Telerex Study Number )
Study First Received: May 29, 2008
Results First Received: March 28, 2017
Last Updated: March 28, 2017