Solid Tumors
Conditions
Keywords
Solid tumors
Brief summary
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol
Interventions
DRUGSunitinib
Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior SU011248 Protocol. * Eligible to continue SU011248 treatment.
Exclusion criteria
* Uncontrolled CNS metastasis. * Unfit to receive SU011248.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Treatment | Baseline up to Day 28 after last dose of study treatment |
Countries
Australia, Canada, France, Greece, Italy, Netherlands, Singapore, Sweden, Switzerland, United Kingdom, United States
Participant flow
Recruitment details
Participants were recruited from prior studies in which they received sunitinib.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator's discretion. | 311 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 53 |
| Overall Study | Decision of Sponsor | 11 |
| Overall Study | Enrolled, Not treated | 3 |
| Overall Study | Lack of Efficacy | 213 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 31 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age Continuous | 58.5 Years STANDARD_DEVIATION 11.62 |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 198 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 299 / 311 |
| serious Total, serious adverse events | 118 / 311 |
Outcome results
Primary
Duration of Treatment
Time frame: Baseline up to Day 28 after last dose of study treatment
Population: The intent-to-treat population included all participants who were enrolled in the study and received at least 1 dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib | Duration of Treatment | 190 Days |