Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 9, 2012
Results First Submitted Date  ICMJE July 27, 2015
Results First Posted Date  ICMJE February 23, 2016
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE July 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Objective Response Rate [ 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) ]
    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
  • Clinical Benefit Rate [ 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) ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • Objective Response Rate [ Time Frame: CT scan or MRI every 6 weeks until progression and this assessment will be stopped at the moment of study closure, it is 6 months after last dose to last subject ]
  • Disease control rate [ Time Frame: CT scan or MRI every 6 weeks until progression and this assessment will be stopped at the moment of study closure, it is 6 months after last dose to last subject ]
Change History Complete list of historical versions of study NCT01530334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Progression Free Survival [ 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) ]
    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.
  • Overall Survival (OS) [ 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) ]
    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.
  • Treatment Duration With Gefitinib [ 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) ]
    Treatment duration was calculated from the date of the first to the date of the last intake.
  • Time to Worsening of Disease Related Symptoms [ 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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • Progression free survival (PFS) [ Time Frame: CT scan or MRI every 6 weeks until progression and this assessment will be stopped at the moment of study closure, it is 6 months after last dose to last subject ]
  • Duration of therapy (interval between1st dose and last dose of study drug)Overall Survival (OS) [ Time Frame: Until progression disease or withdrawal criteria met;until last subject last visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Official Title  ICMJE A Phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA) as 3rd Line Treatment Re-challenge in Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Who Responded to Gefitinib in 1st Line and Progressed After 2nd Line Chemotherapy
Brief Summary the primary objective is to characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC
Detailed Description A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA�) as 3rd line treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and who responded to gefitinib in 1st line and progressed after 2nd line chemotherapy
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE Drug: Gefitinib 250mg
Gefitinib 250mg once daily
Other Name: Iressa
Study Arms  ICMJE Experimental: open label single arm with Gefitinib 250MG once daily
Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal
Intervention: Drug: Gefitinib 250mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2014)
61
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
92
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria at screening (Visit 1) and at Start of Study Treatment (Visit 2):

  • Provision of informed consent prior to any study specific procedures.
  • Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as it was determined before starting the first gefitinib treatment by using a well-validated and robust methodology: adenocarcinoma, including Bronchoalveolar Carcinoma (BAC), squamous cell carcinoma, large cell carcinoma, adenosquamous carcinoma or undifferentiated carcinoma or not-otherwise specified NSCLC.

    • Female or male patients aged 18 years or over with Locally advanced or metastatic stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV (metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who have already received gefitinib with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st gefitinib treatment and progressing during or after a subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy.
    • Measurable disease defined as at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with spiral CT or MRI and which is suitable for accurate repeated measurements.
    • WHO / ECOG / Zubrod performance status 0-2.

Exclusion Criteria:

  • Known severe hypersensitivity to gefitinib or any of the excipients of the product
  • Prior EGFR TKIs except gefitinib followed by subsequent anti-cancer treatment (including chemotherapy and excluding EGFR-TKIs).

Previous adjuvant chemotherapy is allowed. Prior surgery or radiotherapy must be completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment with no persistent radiation toxicity.

  • Progression disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with gefitinib
  • Not progressing during or after the last anti-cancer treatment.
  • Considered to require radiotherapy to the lung at the time of study entry or in the near future
  • Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
  • Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
  • Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of < 70 Torr
  • Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
  • Pregnancy or breast-feeding
  • As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Life expectancy of less than 12 weeks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530334
Other Study ID Numbers  ICMJE D7913L00138
EUDRACT n 2011-005157-31
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilberto Riggi, MD MEDICAL DIRECTOR AstraZeneca SpA, Medical Dept., Basiglio, ITALY
Principal Investigator: Filippo Marinis, MD S.Camillo-Forlanini High Specialization Hospitals, Rome, ITALY
Study Director: Silvia Ferrari, MD AstraZeneca SpA, Medical Dept., Basiglio, ITALY
PRS Account AstraZeneca
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP