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AUY922 for Advanced ALK-positive NSCLC

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ClinicalTrials.gov Identifier: NCT01752400
Recruitment Status : Completed
First Posted : December 19, 2012
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alice Shaw, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Intervention Drug: AUY922
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AUY922
Hide Arm/Group Description

Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes

AUY922

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title AUY922
Hide Arm/Group Description

Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes

AUY922

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
52.5
(42 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
5
  83.3%
Male
1
  16.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 6 participants
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
Smoking Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Never Smoker
2
  33.3%
Light Smoker (≤ 10 pack years)
2
  33.3%
Heavy Smoker (>10 pack years)
2
  33.3%
[1]
Measure Description: A pack year is the number of packs of cigarettes (1 pack= 20 cigarettes) smoked per day multiplied by the number of years smoking.
Median Number of Prior Lines of Therapy  
Median (Full Range)
Unit of measure:  Prior Lines of Therapy
Number Analyzed 6 participants
3
(2 to 4)
Previous ALK Inhibitors   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants
Crizotinib 5
Alectinib 1
Certinib 2
[1]
Measure Description:

ALK: anaplastic lymphoma kinase

Participants that received more than one ALK inhibitor were counted once for each inhibitor received

1.Primary Outcome
Title Objective Response Rate
Hide Description

The number of participants that achieved either a complete response (CR) or a partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

  • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.
  • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Baseline and then every six weeks (± 7 days), until the time of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Progression-free Survival
Hide Description

Progression free survival is measured as the number of months from date of study entry to date of progression or death, whichever comes first. Progression is assessed using RECIST v1.1.

Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.

Time Frame From the start of treatment until the time of death or progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: Months
1.43
(1.3 to 2.8)
3.Secondary Outcome
Title Disease Control Rate
Hide Description

The number of participants that achieved disease control, which includes complete responses, partial responses or stable disease as assessed by RECIST v1.1

  • Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.
  • Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
  • Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame Baseline and then every six weeks (± 7 days), until the time of disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
CR
0
   0.0%
PR
3
  50.0%
SD
3
  50.0%
4.Secondary Outcome
Title Number of Participants Who Develop Adverse Events on AUY922
Hide Description The number of participants that developed any grade adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)
Time Frame From the start of treatment until 30 days after last dose was received
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
5.Secondary Outcome
Title Number of Participants With Concurrent KRAS Mutations
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
KRAS Mutation
0
   0.0%
Negative for KRAS Mutation
2
  33.3%
Unknown Mutation Status
4
  66.7%
6.Secondary Outcome
Title ALK Translocation Variant Type
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data unavailable for all six participants
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title ALK Mutation Status
Hide Description The number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies.
Time Frame Baseline, end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available for the other 5 participants
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
ALK Mutation
1
 100.0%
No ALK Mutation
0
   0.0%
8.Secondary Outcome
Title Median Overall Survival
Hide Description The median duration of time from the start of treatment until the time of death or until the participant withdraws participation in the trial.
Time Frame From the start of treatment until death or withdrawal from the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AUY922
Hide Arm/Group Description:
Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
Overall Number of Participants Analyzed 6
Median (95% Confidence Interval)
Unit of Measure: Months
26.87
(9.03 to 26.87)
Time Frame From the start of treatment until 30 days after the last dose of the study drug was received. Treatment is continued until disease progression, unacceptable toxicity, participant withdrawal, death, or discontinuation from the study for any other reason.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AUY922
Hide Arm/Group Description Via intravenous infusion on Days 1, 8 and 15 of each 21 day cycle (once per week). Infusion lasts approximately 60 minutes
All-Cause Mortality
AUY922
Affected / at Risk (%)
Total   1/6 (16.67%)    
Show Serious Adverse Events Hide Serious Adverse Events
AUY922
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Gastrointestinal disorders   
Abdominal Pain  1  1/6 (16.67%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, progressive disease  1  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AUY922
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/6 (16.67%)  1
Thrombotic thrombocytopenic purpura  1  1/6 (16.67%)  1
Eye disorders   
Eye disorders - Other, specify  1  4/6 (66.67%)  5
Gastrointestinal disorders   
Abdominal pain  1  2/6 (33.33%)  3
Constipation  1  2/6 (33.33%)  2
Diarrhea  1  4/6 (66.67%)  5
Nausea  1  1/6 (16.67%)  1
General disorders   
Fatigue  1  3/6 (50.00%)  3
Infections and infestations   
Infections and infestations - Other, specify  1  1/6 (16.67%)  1
Lung infection  1  1/6 (16.67%)  2
Investigations   
Alanine aminotransferase increased  1  1/6 (16.67%)  1
Alkaline phosphatase increased  1  2/6 (33.33%)  2
Aspartate aminotransferase increased  1  1/6 (16.67%)  2
INR increased  1  1/6 (16.67%)  1
Investigations - Other, specify  1  1/6 (16.67%)  1
Metabolism and nutrition disorders   
Alkalosis  1  1/6 (16.67%)  1
Anorexia  1  1/6 (16.67%)  1
Hypomagnesemia  1  1/6 (16.67%)  1
Hyponatremia  1  1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorder - Other, specify  1  1/6 (16.67%)  1
Myalgia  1  1/6 (16.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/6 (16.67%)  1
Psychiatric disorders   
Anxiety  1  1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Alice Shaw, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-724-4000
EMail: ashaw1@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Alice Shaw, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01752400     History of Changes
Other Study ID Numbers: 12-458
First Submitted: December 7, 2012
First Posted: December 19, 2012
Results First Submitted: March 5, 2018
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018