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

NCT01530334 | Completed Phase 2 Results

• 2 other identifiers: D7913L00138EUDRACT n 2011-005157-31
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 24

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

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  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

  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

  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

  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)

Secondary Outcomes (4)

• Progression Free Survival

  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)

• Overall Survival (OS)

  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)

• Treatment Duration With Gefitinib

  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)

• Time to Worsening of Disease Related Symptoms

  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)

Study Arms (1)

open label single arm with Gefitinib 250MG once daily

EXPERIMENTAL

Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal

Drug: Gefitinib 250mg

Interventions

Gefitinib 250mg DRUG

Gefitinib 250mg once daily

Also known as: Iressa

open label single arm with Gefitinib 250MG once daily

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (24)

Research Site

Alessandria, Italy

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Bologna, Italy

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Brescia, Italy

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Cona, Italy

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Florence, Italy

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Genova, Italy

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Lecce, Italy

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Macerata, Italy

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Meldola, Italy

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Milan, Italy

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Monza, Italy

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Napoli, Italy

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Novara, Italy

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Parma, Italy

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Perugia, Italy

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Pordenone, Italy

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Ravenna, Italy

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Rimini, Italy

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Roma, Italy

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Rozzano, Italy

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Torino, Italy

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Treviso, Italy

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Udine, Italy

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Verona, Italy

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MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Claudio Iannacone
• Organization: SPARC CONSULTING SRL

info@sparcconsulting.com

+39 0243119667

Study Officials

• Gilberto Riggi, MD MEDICAL DIRECTOR

  AstraZeneca SpA, Medical Dept., Basiglio, ITALY

  STUDY DIRECTOR

• Filippo Marinis, MD

  S.Camillo-Forlanini High Specialization Hospitals, Rome, ITALY

  PRINCIPAL INVESTIGATOR

• Silvia Ferrari, MD

  AstraZeneca SpA, Medical Dept., Basiglio, ITALY

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 9, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 23, 2016
• Results First Posted: February 23, 2016

Record last verified: 2016-01

Locations

IT (24)