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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01530334
First received: January 31, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Lung Cancer
Drug: Gefitinib 250mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    CT scan or MRI

  • 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 ] [ Designated as safety issue: No ]
    CT scan or MRI


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    CT scan or MRI

  • 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 ] [ Designated as safety issue: No ]
    CT scan or MRI


Enrollment: 61
Study Start Date: July 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: open label single arm with Gefitinib 250MG once daily
Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal
Drug: Gefitinib 250mg
Gefitinib 250mg once daily
Other Name: Iressa

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530334

Locations
Italy
Research Site
Alessandria, Italy
Research Site
Bologna, Italy
Research Site
Brescia, Italy
Research Site
Cona, Italy
Research Site
Firenze, Italy
Research Site
Genova, Italy
Research Site
Lecce, Italy
Research Site
Macerata, Italy
Research Site
Meldola, Italy
Research Site
Milano, Italy
Research Site
Monza, Italy
Research Site
Napoli, Italy
Research Site
Novara, Italy
Research Site
Parma, Italy
Research Site
Perugia, Italy
Research Site
Pordenone, Italy
Research Site
Ravenna, Italy
Research Site
Rimini, Italy
Research Site
Roma, Italy
Research Site
Rozzano, Italy
Research Site
Torino, Italy
Research Site
Treviso, Italy
Research Site
Udine, Italy
Research Site
Verona, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01530334     History of Changes
Other Study ID Numbers: D7913L00138, EUDRACT n 2011-005157-31
Study First Received: January 31, 2012
Last Updated: June 30, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014