Trial Outcomes & Findings for Iressa Follow-up Trial (NCT NCT00357734)
NCT ID: NCT00357734
Last Updated: 2016-08-30
Results Overview
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
COMPLETED
PHASE3
14 participants
Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
2016-08-30
Participant Flow
First subject enrolled: 16 June 2005, Last subject last visit: 18 May 2015. The study was conducted in Germany.
Participant milestones
| Measure |
Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
Patients Received 250 mg of ZD1839
|
13
|
|
Overall Study
Patient Received 500 mg of ZD1839
|
1
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iressa Follow-up Trial
Baseline characteristics by cohort
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Age, Continuous
|
66 Years
n=39 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Number of Serious Adverse Events (SAEs)
|
13 number of SAEs
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Number of Serious Adverse Events (SAEs) Related to ZD1839
|
0 Number of SAEs related to ZD1839
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Number of Other Adverse Events (AEs)
|
40 number of other AEs
|
PRIMARY outcome
Timeframe: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (SAEs) occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease.
Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Number of Other Adverse Events (AEs) Related to ZD1839
|
19 number of other AEs related to ZD1839
|
SECONDARY outcome
Timeframe: From randomization until progression or death (up to 120 months)Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Progression-free Survival (PFS)
|
26.5 Months
Interval 11.0 to 56.0
|
SECONDARY outcome
Timeframe: From randomization until death (up to 120 months)Outcome measures
| Measure |
Gefitinib (ZD1839)
n=14 Participants
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Overall Survival (OS)
|
23.5 Months
Interval 15.0 to 56.0
|
Adverse Events
Gefitinib (ZD1839)
Serious adverse events
| Measure |
Gefitinib (ZD1839)
n=14 participants at risk
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Gastrointestinal disorders
Duodenitis
|
7.1%
1/14
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14
|
|
Gastrointestinal disorders
Ascites
|
7.1%
1/14
|
|
Infections and infestations
Bronchopneumonia
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
7.1%
1/14
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
7.1%
1/14
|
|
General disorders
Death
|
7.1%
1/14
|
|
General disorders
Asthenia
|
7.1%
1/14
|
|
Gastrointestinal disorders
Haematemesis
|
7.1%
1/14
|
|
General disorders
General physical health deterioration
|
7.1%
1/14
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14
|
Other adverse events
| Measure |
Gefitinib (ZD1839)
n=14 participants at risk
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
7.1%
1/14
|
|
Nervous system disorders
DIZZINESS
|
7.1%
1/14
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
7.1%
1/14
|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.1%
1/14
|
|
Gastrointestinal disorders
COLITIS
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
7.1%
1/14
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
2/14
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.1%
1/14
|
|
Infections and infestations
EPIDIDYMITIS
|
7.1%
1/14
|
|
General disorders
FATIGUE
|
7.1%
1/14
|
|
Hepatobiliary disorders
GALLBLADDER PAIN
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
7.1%
1/14
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
7.1%
1/14
|
|
Gastrointestinal disorders
NAUSEA
|
21.4%
3/14
|
|
General disorders
OEDEMA
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
7.1%
1/14
|
|
Infections and infestations
PARONYCHIA
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
7.1%
1/14
|
|
Gastrointestinal disorders
RECTAL HEMORRHAGE
|
7.1%
1/14
|
|
Gastrointestinal disorders
VOMITING
|
21.4%
3/14
|
|
Investigations
WEIGHT DECREASED
|
7.1%
1/14
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
7.1%
1/14
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60