AMG 102 and Erlotinib for Advanced Non-Small Cell Lung Cancer
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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
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Sponsor:
Ahmad Tarhini
Collaborator:
Amgen
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Carcinoma, Non-Small-Cell Lung |
Intervention |
Drug: AMG 102 and erlotinib |
Enrollment | 49 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | AMG 102 + Erlotinib |
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[Not Specified] |
Period Title: Phase I RP2D AMG 102 + Erlotinib | |
Started | 7 |
Completed | 7 |
Not Completed | 0 |
Period Title: Phase II AMG 102 + Erlotinib | |
Started | 49 [1] |
Response-Evaluable | 45 |
Completed | 45 |
Not Completed | 4 |
Reason Not Completed | |
Death | 1 |
Physician Decision | 2 |
Withdrawal by Subject | 1 |
[1]
Includes 7 participants from Phase 1 part of study.
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Baseline Characteristics
Arm/Group Title | AMG 102 + Erlotinib | |
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[Not Specified] | |
Overall Number of Baseline Participants | 45 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 45 participants | |
65
(35 to 82)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 45 participants | |
Female |
20 44.4%
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Male |
25 55.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Ahmad Tarhini, MD |
Organization: | University of Pittsburgh |
Phone: | (412) 648-6578 |
EMail: | tarhiniaa@upmc.edu |
Responsible Party: | Ahmad Tarhini, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01233687 |
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 |