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Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

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ClinicalTrials.gov Identifier: NCT00988169
Recruitment Status : Terminated
First Posted : October 2, 2009
Results First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
Ascenta Therapeutics
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Drug: oral erlotinib and pulsed doses of oral AT-101
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral Erlotinib and Pulsed Doses of Oral AT-101
Hide Arm/Group Description Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Oral Erlotinib and Pulsed Doses of Oral AT-101
Hide Arm/Group Description Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  66.7%
>=65 years
2
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
1.Primary Outcome
Title Radiographic Objective Response Rate
Hide Description (CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Time Frame 21 days after cycle one
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oral Erlotinib and Pulsed Doses of Oral AT-101
Hide Arm/Group Description:
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Minor Response (MR) 1
Stable Disease (SD) 3
Partial Response (PR) 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Erlotinib and Pulsed Doses of Oral AT-101
Hide Arm/Group Description Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
All-Cause Mortality
Oral Erlotinib and Pulsed Doses of Oral AT-101
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oral Erlotinib and Pulsed Doses of Oral AT-101
Affected / at Risk (%) # Events
Total   1/5 (20.00%)    
Cardiac disorders   
Hypotension  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Erlotinib and Pulsed Doses of Oral AT-101
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
ALT, SGPT  1  3/5 (60.00%)  3
AST, SGOT  1  1/5 (20.00%)  1
Neutrophils/granulocytes  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Diarrhea  1  1/5 (20.00%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  2/5 (40.00%)  2
Nausea  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
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: Dr. Mark Kris
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4205
EMail: krism@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00988169     History of Changes
Other Study ID Numbers: 09-026
First Submitted: September 30, 2009
First Posted: October 2, 2009
Results First Submitted: October 19, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015