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AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01233687
First received: November 2, 2010
Last updated: July 20, 2016
Last verified: July 2016
Results First Received: January 12, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: AMG 102 and 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AMG 102 + Erlotinib No text entered.

Participant Flow for 2 periods

Period 1:   Phase I RP2D AMG 102 + Erlotinib
    AMG 102 + Erlotinib
STARTED   7 
COMPLETED   7 
NOT COMPLETED   0 

Period 2:   Phase II AMG 102 + Erlotinib
    AMG 102 + Erlotinib
STARTED   49 [1] 
Response-Evaluable   45 
COMPLETED   45 
NOT COMPLETED   4 
Death                1 
Physician Decision                2 
Withdrawal by Subject                1 
[1] Includes 7 participants from Phase 1 part of study.



  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.
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Reporting Groups
  Description
AMG 102 + Erlotinib No text entered.

Baseline Measures
   AMG 102 + Erlotinib 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Years]
Median (Full Range)
 65 
 (35 to 82) 
Gender 
[Units: Participants]
 
Female   20 
Male   25 


  Outcome Measures
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1.  Primary:   Percentage of Participants That Experienced a Dose Limiting Toxicity   [ Time Frame: During first cycle of treatment (3 weeks) ]

2.  Primary:   Disease Control Rate (DCR)   [ Time Frame: Six weeks from initiation of treatment with AMG 102 + Erlotinib ]

3.  Secondary:   Objective Response Rate (ORR/Clinical Response)   [ Time Frame: Up to 6 months ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 24 months (after the first patient is accrued) ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 24 months (after the first evaluable patient is accrued) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ahmad Tarhini, MD
Organization: University of Pittsburgh
phone: (412) 648-6578
e-mail: tarhiniaa@upmc.edu



Responsible Party: Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01233687     History of Changes
Other Study ID Numbers: 10-058
Study First Received: November 2, 2010
Results First Received: January 12, 2016
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration