Trial Outcomes & Findings for Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment (NCT NCT01530334)
NCT ID: NCT01530334
Last Updated: 2016-02-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
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)
Results posted on
2016-02-23
Participant Flow
Overall, 61 patients were enrolled from July 2012 to July 2014 from 25 medical clinics across Italy: of these, 59 received gefitinib.
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
Participant milestones
| Measure |
Gefitinib
250 mg/die, oral
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Gefitinib
250 mg/die, oral
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
unknown reason
|
1
|
|
Overall Study
Progressive disease
|
47
|
Baseline Characteristics
Iressa Re-Challenge in Advanced NSCLC EGFR M+ Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Baseline characteristics by cohort
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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)
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
Outcome measures
| Measure |
Gefitinib
n=61 partecipants
250 mg/die, oral
|
|---|---|
|
Objective Response Rate
|
3 Patients
|
PRIMARY outcome
Timeframe: 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)Population: CBR was analyzed both on FAS and EFS population
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
Outcome measures
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Clinical Benefit Rate
|
32 Patients
Interval 40.2 to 64.5
|
SECONDARY outcome
Timeframe: 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)Population: PFS was analysed on FAS and EFS population
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.
Outcome measures
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Progression Free Survival
|
84 Days
Interval 74.0 to 94.0
|
SECONDARY outcome
Timeframe: 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)Population: Analysis conducted both in FAS and EFS population
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.
Outcome measures
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Overall Survival (OS)
|
311 days
Interval 268.0 to 431.0
|
SECONDARY outcome
Timeframe: 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)Population: Analysis performed on EFS \& FAS population
Treatment duration was calculated from the date of the first to the date of the last intake.
Outcome measures
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Treatment Duration With Gefitinib
|
108 days
Interval 92.0 to 169.0
|
SECONDARY outcome
Timeframe: 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)Population: Analysis performed on EFS \& FAS population
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.
Outcome measures
| Measure |
Gefitinib
n=61 Participants
250 mg/die, oral
|
|---|---|
|
Time to Worsening of Disease Related Symptoms
|
93 days
Interval 71.0 to 109.0
|
Adverse Events
Gefitinib
Serious events: 10 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gefitinib
n=58 participants at risk
250 mg/die, oral
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
2/58 • Number of events 2 • 24 months
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
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Cardiac disorders
Cardiac failure
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Cardiac disorders
Myocardial infarction
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Infections and infestations
Sepsis
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Nervous system disorders
Cognitive disorder
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Nervous system disorders
Epilepsy
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
General disorders
General physical health deterioration
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Injury, poisoning and procedural complications
Head injury
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Renal and urinary disorders
Renal failure acute
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.7%
1/58 • Number of events 1 • 24 months
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
|
Other adverse events
| Measure |
Gefitinib
n=58 participants at risk
250 mg/die, oral
|
|---|---|
|
Gastrointestinal disorders
Diarrohea
|
27.6%
16/58 • Number of events 21 • 24 months
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
|
|
Gastrointestinal disorders
Vomiting
|
15.5%
9/58 • Number of events 11 • 24 months
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
|
|
Gastrointestinal disorders
Nausea
|
10.3%
6/58 • Number of events 8 • 24 months
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
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.2%
3/58 • Number of events 3 • 24 months
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
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.5%
9/58 • Number of events 13 • 24 months
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
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.6%
5/58 • Number of events 5 • 24 months
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
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
5/58 • Number of events 6 • 24 months
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
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.2%
3/58 • Number of events 3 • 24 months
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
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
5.2%
3/58 • Number of events 5 • 24 months
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
|
|
General disorders
Asthenia
|
8.6%
5/58 • Number of events 8 • 24 months
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
|
|
General disorders
Chest pain
|
8.6%
5/58 • Number of events 5 • 24 months
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
|
|
General disorders
Fatigue
|
8.6%
5/58 • Number of events 5 • 24 months
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
|
|
General disorders
Pyrexia
|
8.6%
5/58 • Number of events 6 • 24 months
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
|
|
General disorders
General physical health deterioration
|
6.9%
4/58 • Number of events 5 • 24 months
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
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.6%
5/58 • Number of events 6 • 24 months
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
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
4/58 • Number of events 4 • 24 months
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
|
|
Infections and infestations
Folliculitis
|
5.2%
3/58 • Number of events 3 • 24 months
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
|
|
Infections and infestations
Paronychia
|
5.2%
3/58 • Number of events 4 • 24 months
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
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
6/58 • Number of events 6 • 24 months
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
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
4/58 • Number of events 4 • 24 months
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
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
6/58 • Number of events 6 • 24 months
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
|
|
Eye disorders
Conjunctivitis
|
8.6%
5/58 • Number of events 12 • 24 months
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
|
|
Vascular disorders
Hypertension
|
6.9%
4/58 • Number of events 4 • 24 months
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
|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
3/58 • Number of events 3 • 24 months
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
|
|
Ear and labyrinth disorders
Vertigo
|
5.2%
3/58 • Number of events 4 • 24 months
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER