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Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment (ICARUS)

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ClinicalTrials.gov Identifier: NCT01530334
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Intervention Drug: Gefitinib 250mg
Enrollment 61
Recruitment Details Overall, 61 patients were enrolled from July 2012 to July 2014 from 25 medical clinics across Italy: of these, 59 received gefitinib.
Pre-assignment Details The study foresees a screening period of 28 days where the investigator had to obtain signed informed consent from the potential patient before any study specific procedures are performed, and determine patient eligibility. At the end of the screening period the patient started the treatment with gefitinib
Arm/Group Title Gefitinib
Hide Arm/Group Description 250 mg/die, oral
Period Title: Overall Study
Started 61
Completed 10
Not Completed 51
Reason Not Completed
Adverse Event             3
unknown reason             1
Progressive disease             47
Arm/Group Title Gefitinib
Hide Arm/Group Description 250 mg/die, oral
Overall Number of Baseline Participants 61
Hide Baseline Analysis Population Description
The overall number of patients was 61 (FAS population). FAS population was defined as all screened patients enrolled in the study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants
66.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants
Female
45
  73.8%
Male
16
  26.2%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 61 participants
61
[1]
Measure Description: All patients were Caucasian (61, 100%)
1.Primary Outcome
Title Objective Response Rate
Hide Description

Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.

Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR

Time Frame every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed both in the FAS population (i.e. all enrolled patients into the study) and in EFS population (i.e. all screened patients who entered and received at least one dose of study agent)
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Overall Number of Units Analyzed
Type of Units Analyzed: Partecipants
61
Measure Type: Number
Unit of Measure: Patients
3
2.Primary Outcome
Title Clinical Benefit Rate
Hide Description

Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.

Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for>= 6 weeks. Objective response rate (RR)=CR+PR

Time Frame every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
CBR was analyzed both on FAS and EFS population
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Measure Type: Number
Unit of Measure: Patients
32
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free Survival was calculated as the time from the first dose of gefitinib study treatment until the date of (i) progression or (ii) death from any cause in the absence of progression.
Time Frame every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
PFS was analysed on FAS and EFS population
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: Days
84
(74 to 94)
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was calculated as the time from the first dose until the day of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last follow-up date.
Time Frame every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis conducted both in FAS and EFS population
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: days
311
(268 to 431)
5.Secondary Outcome
Title Treatment Duration With Gefitinib
Hide Description Treatment duration was calculated from the date of the first to the date of the last intake.
Time Frame every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on EFS & FAS population
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: days
108
(92 to 169)
6.Secondary Outcome
Title Time to Worsening of Disease Related Symptoms
Hide Description Time to worsening of disease related symptoms (LCS) Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of ‘worsened’ without a subsequent response of ‘improved’ or ‘no change’ within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.
Time Frame every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed on EFS & FAS population
Arm/Group Title Gefitinib
Hide Arm/Group Description:
250 mg/die, oral
Overall Number of Participants Analyzed 61
Median (95% Confidence Interval)
Unit of Measure: days
93
(71 to 109)
Time Frame 24 months
Adverse Event Reporting Description Adverse Events and Serious Adverse Events were collected from the time of screening informed consent throughout the treatment period, until 30 days after discontinuation of gefitinib treatment. Adverse events were based on sign and symptoms reported by the patients and on examinations and test
 
Arm/Group Title Gefitinib
Hide Arm/Group Description 250 mg/die, oral
All-Cause Mortality
Gefitinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gefitinib
Affected / at Risk (%) # Events
Total   10/58 (17.24%)    
Cardiac disorders   
Cardiac failure  1  1/58 (1.72%)  1
Myocardial infarction  1  1/58 (1.72%)  1
General disorders   
General physical health deterioration  1  1/58 (1.72%)  1
Infections and infestations   
Gastroenteritis  1  1/58 (1.72%)  1
Sepsis  1  1/58 (1.72%)  1
Injury, poisoning and procedural complications   
Head injury  1  1/58 (1.72%)  1
Nervous system disorders   
Cognitive disorder  1  1/58 (1.72%)  1
Epilepsy  1  1/58 (1.72%)  1
Renal and urinary disorders   
Renal failure acute  1  1/58 (1.72%)  1
Reproductive system and breast disorders   
Metrorrhagia  1  1/58 (1.72%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  2/58 (3.45%)  2
Pulmonary embolism  1  1/58 (1.72%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gefitinib
Affected / at Risk (%) # Events
Total   42/58 (72.41%)    
Blood and lymphatic system disorders   
Anaemia  1  3/58 (5.17%)  3
Ear and labyrinth disorders   
Vertigo  1  3/58 (5.17%)  4
Eye disorders   
Conjunctivitis  1  5/58 (8.62%)  12
Gastrointestinal disorders   
Diarrohea  1  16/58 (27.59%)  21
Vomiting  1  9/58 (15.52%)  11
Nausea  1  6/58 (10.34%)  8
Abdominal pain upper  1  3/58 (5.17%)  3
General disorders   
Asthenia  1  5/58 (8.62%)  8
Chest pain  1  5/58 (8.62%)  5
Fatigue  1  5/58 (8.62%)  5
Pyrexia  1  5/58 (8.62%)  6
General physical health deterioration  1  4/58 (6.90%)  5
Infections and infestations   
Folliculitis  1  3/58 (5.17%)  3
Paronychia  1  3/58 (5.17%)  4
Metabolism and nutrition disorders   
Decreased appetite  1  6/58 (10.34%)  6
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain  1  5/58 (8.62%)  6
Bone pain  1  4/58 (6.90%)  4
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  6/58 (10.34%)  6
Cough  1  4/58 (6.90%)  4
Skin and subcutaneous tissue disorders   
Rash  1  9/58 (15.52%)  13
Dry skin  1  5/58 (8.62%)  5
Pruritus  1  5/58 (8.62%)  6
Dermatitis acneiform  1  3/58 (5.17%)  3
Skin toxicity  1  3/58 (5.17%)  5
Vascular disorders   
Hypertension  1  4/58 (6.90%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 17
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Claudio Iannacone
Organization: SPARC CONSULTING SRL
Phone: +39 0243119667
EMail: info@sparcconsulting.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01530334     History of Changes
Other Study ID Numbers: D7913L00138
EUDRACT n 2011-005157-31
First Submitted: January 31, 2012
First Posted: February 9, 2012
Results First Submitted: July 27, 2015
Results First Posted: February 23, 2016
Last Update Posted: February 23, 2016