Breast Cancer, Lung Cancer
Conditions
Keywords
lung cancer, breast cancer
Brief summary
The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).
Interventions
DRUGGefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent to participate in the trial. * Female or male aged 18 years and over. * Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation
Exclusion criteria
* Known severe hypersensitivity to ZD1839 * Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort. * Withdrawal from a parent ZD1839 trial because of tumor progress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Serious Adverse Events (SAEs) | 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 |
| Number of Serious Adverse Events (SAEs) Related to ZD1839 | 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. |
| Number of Other Adverse Events (AEs) | 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. |
| Number of Other Adverse Events (AEs) Related to ZD1839 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 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. |
| Overall Survival (OS) | From randomization until death (up to 120 months) | — |
Countries
Germany
Participant flow
Recruitment details
First subject enrolled: 16 June 2005, Last subject last visit: 18 May 2015. The study was conducted in Germany.
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib (ZD1839) ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Gefitinib (ZD1839) |
|---|---|
| Age, Continuous | 66 Years |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 14 |
| serious Total, serious adverse events | 4 / 14 |
Outcome results
Primary
Number of Other Adverse Events (AEs)
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib (ZD1839) | Number of Other Adverse Events (AEs) | 40 number of other AEs |
Primary
Number of Other Adverse Events (AEs) Related to ZD1839
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib (ZD1839) | Number of Other Adverse Events (AEs) Related to ZD1839 | 19 number of other AEs related to ZD1839 |
Primary
Number of Serious Adverse Events (SAEs)
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
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib (ZD1839) | Number of Serious Adverse Events (SAEs) | 13 number of SAEs |
Primary
Number of Serious Adverse Events (SAEs) Related to ZD1839
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.
Time frame: 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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib (ZD1839) | Number of Serious Adverse Events (SAEs) Related to ZD1839 | 0 Number of SAEs related to ZD1839 |
Secondary
Overall Survival (OS)
Time frame: From randomization until death (up to 120 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib (ZD1839) | Overall Survival (OS) | 23.5 Months |
Secondary
Progression-free Survival (PFS)
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.
Time frame: From randomization until progression or death (up to 120 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib (ZD1839) | Progression-free Survival (PFS) | 26.5 Months |