An interventional study of SU011248 in Neoplasms, sponsored by Pfizer. Completed at 62 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-24.
Sponsored by Pfizer · Not applicable, Interventional, and Treatment
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SU011248
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
Also known as: Sutent/Sunitinib
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
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
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
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
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.
| Milestone | Sunitinib |
|---|---|
| Started | 123 |
| Treated | 122 |
| Completed | 0 |
| Not completed | 123 |
| Withdrew: Lack of efficacy | 67 |
| Withdrew: Adverse event | 16 |
| Withdrew: Death | 9 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Study terminated by sponsor | 12 |
| Withdrew: Other | 10 |
| Withdrew: Enrolled, not treated | 1 |
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.
| participants | Sunitinib |
|---|---|
| Adverse Events | 119 |
| Serious Adverse Events | 35 |
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).
No measurements were reported for this outcome.
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").
No measurements were reported for this outcome.
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 \[PD\]).
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | — | 35/122 (28.7%) | 115/122 (94.3%) |
| Event | Sunitinib |
|---|---|
| Disease progressionGeneral disorders | 9/122 |
| DehydrationMetabolism and nutrition disorders | 4/122 |
| AnaemiaBlood and lymphatic system disorders | 3/122 |
| MelaenaGastrointestinal disorders | 3/122 |
| Back painMusculoskeletal and connective tissue disorders | 3/122 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/122 |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/122 |
| Rectal haemorrhageGastrointestinal disorders | 2/122 |
| Small intestinal obstructionGastrointestinal disorders | 2/122 |
| VomitingGastrointestinal disorders | 2/122 |
| Event | Sunitinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 49/122 |
| FatigueGeneral disorders | 36/122 |
| NauseaGastrointestinal disorders | 33/122 |
| NeutropeniaBlood and lymphatic system disorders | 32/122 |
| Decreased appetiteMetabolism and nutrition disorders | 27/122 |
| AnaemiaBlood and lymphatic system disorders | 24/122 |
| Oedema peripheralGeneral disorders | 24/122 |
| ConstipationGastrointestinal disorders | 23/122 |
| VomitingGastrointestinal disorders | 22/122 |
| HeadacheNervous system disorders | 20/122 |
| Age Continuous(years) | Sunitinib |
|---|---|
| Mean | 59.9 ± 11.7 |
| Sex: Female, Male(Participants) | Sunitinib |
|---|---|
| Female | 61 |
| Male | 61 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer