Advanced Breast Cancer, Advanced Gastric Cancer, Advanced/Metastatic Non-Small Cell Lung Cancer, Gastrointestinal Stromal Tumor, Hepatocellular Carcinoma, Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Renal Cell Cancer, Non-Small Cell Lung Cancer, Pancreatic Islet Cell Carcinoma, Pancreatic Neuroendocrine Tumor, Thyroid Cancer
Conditions
Keywords
Potentially other tumor types in the future
Brief summary
This is a study using sunitinib for patients ending treatment on a previous sunitinib malate protocol to continue to receive sunitinib. The patient must have been enrolled in one of the following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.
Interventions
DRUGsunitinib
sunitinib
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
* Must have ended treatment from one of the following sunitinib studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib studies may be included in the future.
Exclusion criteria
* See inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | From first day of treatment on the current study up to 28 days post the last dose of study treatment | Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities. |
| Number of Participants With Treatment-emergent AEs (Treatment-Related) | From first day of treatment on the current study up to 28 days post the last dose of study treatment | Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Duration of Clinical Benefit | From the first day of treatment in parent study until last day of treatment in A6181114 study. | Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Colombia, France, Germany, Hong Kong, Mexico, Philippines, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
In this open-label extension study, access to sunitinib was provided to participants who had participated in a previous parent study and who had been judged by the Investigator to have likely clinical benefit from continuing sunitinib dosing.
Pre-assignment details
Participants receiving sunitinib in previous studies began treatment in this study with the last dose they were taking in the parent or extension study. Participants were to continue to access sunitinib on this protocol as long as there was evidence of disease control and/or clinical benefit in the judgment of the Investigator.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily. | 223 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 51 |
| Overall Study | Global deterioration of health status | 7 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Objective progression or relapse | 123 |
| Overall Study | Other | 23 |
| Overall Study | Participant died | 8 |
| Overall Study | Participant refused continued treatment | 7 |
Baseline characteristics
| Characteristic | Sunitinib |
|---|---|
| Age, Continuous | 55.2 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 130 Participants |
| Sex: Female, Male Male | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 219 / 223 |
| serious Total, serious adverse events | 90 / 223 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities)
Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Time frame: From first day of treatment on the current study up to 28 days post the last dose of study treatment
Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants with adverse events (AE) | 221 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants with serious adverse events (SAE) | 90 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants with grade 3 or 4 AEs | 174 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants with grade 5 AEs | 24 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants discontinued due to AEs | 67 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Participants with dose reduction due to AEs | 66 participants |
| Sunitinib | Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) | Temporary discontinuations due to AEs | 146 participants |
Primary
Number of Participants With Treatment-emergent AEs (Treatment-Related)
Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Time frame: From first day of treatment on the current study up to 28 days post the last dose of study treatment
Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants with SAE | 39 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants with grade 3 or 4 AEs | 146 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants with AE | 217 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants with grade 5 AEs | 0 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants discontinued due to AEs | 29 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Participants with dose reduction due to AEs | 64 participants |
| Sunitinib | Number of Participants With Treatment-emergent AEs (Treatment-Related) | Temporary discontinuations due to AEs | 135 participants |
Other Pre-specified
Summary of Duration of Clinical Benefit
Duration of clinical benefit is defined as the length of time participants remain on sunitinib from the first day of treatment on the parent protocol until the end of sunitinib treatment in this study (A6181114). For participants who were on placebo or a comparator drug in the parent study, duration of clinical benefit is defined as the length of time participants are on sunitinib in this study.
Time frame: From the first day of treatment in parent study until last day of treatment in A6181114 study.
Population: The safety population was defined as all participants enrolled in the study who received at least one dose of study drug in this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib | Summary of Duration of Clinical Benefit | 186.6 Weeks | Standard Deviation 68.2 |
| Sunitinib 2 | Summary of Duration of Clinical Benefit | 76.0 Weeks | — |
| Sunitinib 3 | Summary of Duration of Clinical Benefit | 157.5 Weeks | Standard Deviation 6.2 |
| Sunitinib 4 | Summary of Duration of Clinical Benefit | 22.1 Weeks | Standard Deviation 25.2 |
| Sunitinib 5 | Summary of Duration of Clinical Benefit | 122.9 Weeks | Standard Deviation 73.4 |
| Sunitinib 6 | Summary of Duration of Clinical Benefit | 76.6 Weeks | Standard Deviation 69 |
| Sunitinib 7 | Summary of Duration of Clinical Benefit | 71.6 Weeks | Standard Deviation 26.2 |
| Sunitinib 8 | Summary of Duration of Clinical Benefit | 198.9 Weeks | — |
| Sunitinib 9 | Summary of Duration of Clinical Benefit | 142.2 Weeks | Standard Deviation 23.6 |
| Sunitinib 10 | Summary of Duration of Clinical Benefit | 183.6 Weeks | — |
| Sunitinib 11 | Summary of Duration of Clinical Benefit | 227.5 Weeks | Standard Deviation 57.9 |