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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01233687
Recruitment Status : Completed
First Posted : November 3, 2010
Results First Posted : September 1, 2016
Last Update Posted : June 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: AMG 102 and erlotinib

  Participant Flow

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
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

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
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20  44.4% 
Male      25  55.6% 


  Outcome Measures

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

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

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
First Submitted: November 2, 2010
First Posted: November 3, 2010
Results First Submitted: January 12, 2016
Results First Posted: September 1, 2016
Last Update Posted: June 22, 2017