Neoplasms
Conditions
Brief summary
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.
Interventions
DRUGSU011248
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior 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
* Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.
Exclusion criteria
* Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 28 after last dose of study treatment | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline, every 2 months until death or up to 2 years after the last dose of study treatment | Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Progression-Free Survival (PFS) | Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death). |
| Time to Tumor Progression (TTP) | Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]). |
Countries
Canada, France, Germany, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
All participants were recruited from following previous sunitinib trials: NCT00798889, NCT00092001, NCT00137449, A6181049, A6181051, NCT00113516, NCT00265317, NCT00137423, NCT00267748, NCT00243503, NCT00471276, NCT00174434, NCT00528619, NCT00372775, NCT00417885, NCT00428597, and NCT00372567.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 \[4 weeks on study drug, 2 weeks off treatment\]; Schedule 2/1 \[2 weeks on study drug, 1 week off treatment\]; Schedule 2/2 \[2 weeks on study drug, 2 weeks off treatment\]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing). | 122 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Death | 9 |
| Overall Study | Enrolled, Not Treated | 1 |
| Overall Study | Lack of Efficacy | 67 |
| Overall Study | Other | 10 |
| Overall Study | Study Terminated by Sponsor | 12 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age Continuous | 59.9 years STANDARD_DEVIATION 11.7 |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 115 / 122 |
| serious Total, serious adverse events | 35 / 122 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to Day 28 after last dose of study treatment
Population: Intent to treat (ITT) population included all enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse Events | 119 participants |
| Sunitinib | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious Adverse Events | 35 participants |
Other Pre-specified
Overall Survival (OS)
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline, every 2 months until death or up to 2 years after the last dose of study treatment
Population: Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.
Other Pre-specified
Progression-Free Survival (PFS)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death).
Time frame: Baseline, every 2 months until objective tumor progression or death or up to 2 years after the last dose of study medication
Population: Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.
Other Pre-specified
Time to Tumor Progression (TTP)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]).
Time frame: Baseline, every 2 months until objective tumor progression or up to 2 years after the last dose of study medication
Population: Tumor response data were not formally analyzed in this study as individual participant outcomes contributed to conclusions in their prior studies.