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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:
Amgen
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description [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.
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 45 participants
65
(35 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
20
  44.4%
Male
25
  55.6%
1.Primary Outcome
Title Percentage of Participants That Experienced a Dose Limiting Toxicity
Hide Description Determination of the safety and recommended phase II dose of AMG 102 when combined with erlotinib for the treatment of patients with advanced, previously-treated NSCLC.
Time Frame During first cycle of treatment (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
In the absence of DLTs among the first 7 pts treated, AMG 102 + Erlotinib (150 mg) daily (3 weeks) was declared the RP2D.
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 7
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 0)
2.Primary Outcome
Title Disease Control Rate (DCR)
Hide Description Using RECIST v1.1 criteria, DCR was determined by following equation: the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants / the number of complete response (CR) participants + the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
Time Frame Six weeks from initiation of treatment with AMG 102 + Erlotinib
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
60
(47 to 71)
3.Secondary Outcome
Title Objective Response Rate (ORR/Clinical Response)
Hide Description Using RECIST v1.1 criteria, ORR was determined by following equation: the number of partial response (PR) participants / the number of partial response (PR) participants + the number of stable disease (SD) participants + the number of progressive disease (PD) participants.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients
8.8
(0.4 to 18.4)
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival is defined as the time from the start of treatment until first evidence of disease progression, death, or date of last contact. The (median) length of time that subjects with previously-treated advanced NSCLC, who were treated with the combination of AMG 102 and erlotinib, are both alive and free of disease progression as estimated by the Kaplan-Meier method. For participants not known to have died as of the data cut-off date and who did not have PD, the PFS date was censored at the last contact date (contacts considered in the determination of last progression free disease assessment).
Time Frame Up to 24 months (after the first patient is accrued)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 45
Median (90% Confidence Interval)
Unit of Measure: months
2.6
(1.4 to 3.3)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival was computed for all participants and is defined as the time between start of treatment and death. The (median) length of time in months that subjects with previously-treated advanced NSCLC, treated with the combination of AMG 102 and erlotinib, remain alive estimated by the Kaplan-Meier method.
Time Frame Up to 24 months (after the first evaluable patient is accrued)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who who received at least one dose of AMG 102 and had post-treatment imaging studies for response evaluation using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria at six weeks (RESPONSE EVALUABLE)
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 45
Median (90% Confidence Interval)
Unit of Measure: months
6.6
(5.6 to 8.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMG 102 + Erlotinib
Hide Arm/Group Description

Serious and Non-Serious Adverse Events include the events considered at least possibly, probably or definitely related to study treatment.

Non-Serious (Other) Adverse Events include those that occurred with a frequency of more than or equal to 5%.

All-Cause Mortality
AMG 102 + Erlotinib
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
AMG 102 + Erlotinib
Affected / at Risk (%)
Total   18/45 (40.00%) 
Blood and lymphatic system disorders   
Anemia   1/45 (2.22%) 
Gastrointestinal disorders   
Diarrhea   1/45 (2.22%) 
Mucositis oral   1/45 (2.22%) 
Nausea   1/45 (2.22%) 
Vomiting   1/45 (2.22%) 
General disorders   
Edema limbs   1/45 (2.22%) 
Infections and infestations   
Infections and infestations - Other, specify   1/45 (2.22%) 
Nervous system disorders   
Syncope   1/45 (2.22%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   5/45 (11.11%) 
Skin and subcutaneous tissue disorders   
Rash acneiform   1/45 (2.22%) 
Vascular disorders   
Thromboembolic event   4/45 (8.89%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AMG 102 + Erlotinib
Affected / at Risk (%)
Total   45/45 (100.00%) 
Blood and lymphatic system disorders   
Blood and lymphatic system disorders  4/45 (8.89%) 
Anemia  21/45 (46.67%) 
Gastrointestinal disorders   
Vomiting  8/45 (17.78%) 
Nausea  16/45 (35.56%) 
Diarrhea  24/45 (53.33%) 
General disorders   
Edema limbs  8/45 (17.78%) 
Fatigue  18/45 (40.00%) 
Investigations   
Platelet count decreased  5/45 (11.11%) 
Alanine aminotransferase increased  7/45 (15.56%) 
Creatinine increased  7/45 (15.56%) 
Blood bilirubin increased  8/45 (17.78%) 
Aspartate aminotransferase increased  10/45 (22.22%) 
Lymphocyte count decreased  15/45 (33.33%) 
Alkaline phosphatase increased  16/45 (35.56%) 
Metabolism and nutrition disorders   
Anorexia  13/45 (28.89%) 
Hypomagnesemia  20/45 (44.44%) 
Nervous system disorders   
Peripheral sensory neuropathy  3/45 (6.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  8/45 (17.78%) 
Cough  10/45 (22.22%) 
Skin and subcutaneous tissue disorders   
Alopecia  4/45 (8.89%) 
Rash maculo-papular  4/45 (8.89%) 
Pruritus  5/45 (11.11%) 
Skin and subcutaneous tissue disorders - Other, specify  9/45 (20.00%) 
Rash acneiform  30/45 (66.67%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ahmad Tarhini, MD
Organization: University of Pittsburgh
Phone: (412) 648-6578
EMail: tarhiniaa@upmc.edu
Layout table for additonal information
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