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A Study Evaluating Dalotuzumab (MK-0646) in Combination With Erlotinib for Participants With Non-Small Cell Lung Cancer (MK-0646-007)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00654420
First received: March 26, 2008
Last updated: March 6, 2017
Last verified: March 2017
Results First Received: October 28, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Carcinoma, Non-small-cell Lung
Interventions: Drug: Dalotuzumab
Drug: Erlotinib

  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
20 participants were enrolled in Phase I part (dose escalation) and 75 participants were enrolled in Phase II part of study (95 total enrolled).

Reporting Groups
  Description
Ph I: Dalotuzumab 5 mg/kg + Erlotinib During the Phase I part of the study, participants received dalotuzumab intravenously (IV) at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
Ph I: Dalotuzumab 10 mg/kg + Erlotinib During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
Ph II: Dalotuzumab 10 mg/kg + Erlotinib During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
Ph II: Erlotinib During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.

Participant Flow for 2 periods

Period 1:   Phase I (Dose Escalation)
    Ph I: Dalotuzumab 5 mg/kg + Erlotinib   Ph I: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Erlotinib
STARTED   4   16   0   0 
COMPLETED   0   0   0   0 
NOT COMPLETED   4   16   0   0 
Adverse Event                0                1                0                0 
Progressive Disease                4                15                0                0 

Period 2:   Phase II
    Ph I: Dalotuzumab 5 mg/kg + Erlotinib   Ph I: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Erlotinib
STARTED   0   0   37 [1]   38 [1] 
COMPLETED   0   0   0   0 
NOT COMPLETED   0   0   37   38 
Adverse Event                0                0                3                3 
Lost to Follow-up                0                0                0                1 
Physician Decision                0                0                0                4 
Progressive Disease                0                0                29                29 
Withdrawal by Subject                0                0                4                1 
Missing Disposition Record                0                0                1                0 
[1] New participants were enrolled in the Phase II part of the study that did not participate in Phase 1



  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
Ph I: Dalotuzumab 5 mg/kg + Erlotinib During the Phase I part of the study, participants received dalotuzumab IV at 5 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
Ph I: Dalotuzumab 10 mg/kg + Erlotinib During the Phase I part of the study, participants received dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily for 4 weeks. After 4 weeks of therapy, participants in Phase I who did not have disease progression and were satisfactorily tolerating study drug could continue to receive study drug.
Ph II: Dalotuzumab 10 mg/kg + Erlotinib During the Phase II part of the study, participants were randomized to receive dalotuzumab IV at 10 mg/kg weekly plus open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
Ph II: Erlotinib During the Phase II part of the study, participants were randomized to receive open-label erlotinib at 150 mg daily until disease progression or occurrence of unacceptable toxic effects.
Total Total of all reporting groups

Baseline Measures
   Ph I: Dalotuzumab 5 mg/kg + Erlotinib   Ph I: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Dalotuzumab 10 mg/kg + Erlotinib   Ph II: Erlotinib   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   16   37   38   95 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.8  (3.86)   61.9  (7.68)   61.9  (7.83)   58.5  (10.35)   60.2  (8.95) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      2  12.5%      10  27.0%      10  26.3%      22  23.2% 
Male      4 100.0%      14  87.5%      27  73.0%      28  73.7%      73  76.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase I: Number of Participants Experiencing at Least One Dose-Limiting Toxicity (DLT) Adverse Event (AE) During the First Four Weeks of Dalotuzumab Plus Erlotinib Treatment   [ Time Frame: Up to 4 weeks after initiation of treatment ]

2.  Primary:   Phase II: Median Progression Free Survival (PFS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment   [ Time Frame: Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date) ]

3.  Secondary:   Phase II: Median Overall Survival (OS) in Participants Receiving Dalotuzumab Plus Erlotinib Treatment   [ Time Frame: Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date) ]

4.  Secondary:   Phase II: Percentage of Participants With Complete Response (CR) or Partial Response (PR) After Dalotuzumab Plus Erlotinib Treatment (Objective Response Rate [ORR])   [ Time Frame: Duration of time required to collect approximately 49 deaths or PFS events (assessed up to ~20 months total on this study from randomization to cut-off date) ]


  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
No text entered.


  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


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00654420     History of Changes
Other Study ID Numbers: 0646-007
2007_605 ( Other Identifier: Merck Registration Number )
2007-005941-39 ( EudraCT Number )
Study First Received: March 26, 2008
Results First Received: October 28, 2016
Last Updated: March 6, 2017