Gastrointestinal Stromal TumorsNCT00716820
Special Investigation For Gist Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan).
An observational study of Gastrointestinal Stromal Tumors, run by Pfizer.
Trial summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- SUNITINIB MALATE
- Type of treatment
- Pill or oral medicine
- How many people
- 472 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).
Who may be able to join
- Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.
Who cannot join
- Patients not administered SUNITINIB MALATE(Sutent).
About this study
Official title: Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Read the detailed description
All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- SUNITINIB MALATE
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUNITINIB MALATEDrug
Also called SUTENT
SUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated.
The dosage may be decreased according to the patient's clinical condition."
| Study group | Role | What they receive |
|---|---|---|
| SUNITINIB MALATE | Patients taking Sutent. Receives: Drug: SUNITINIB MALATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Measured: MAX 2 Years
Objective Response Rate
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
Measured: MAX 2 Years
Secondary outcomes (9)
Objective Response Rates by KIT Expression Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by KIT expression status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Measured: MAX 2 Years
Objective Response Rates by c-Kit Mutation Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by c-kit mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Measured: MAX 2 Years
Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status
Percentage of participants with objective response based assessment of CR or confirmed PR according to RECIST. Objective response rates by PDGFRα mutation status were calculated according to RECIST and were presented along with the corresponding exact 2-sided 95% CIs.
Measured: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events in Elderly Population
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Elderly population was defined as the participants who aged 65 or older.
Measured: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Measured: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
Measured: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.
Measured: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.). The long-term treatment was defined as the treatment continued more than 24 weeks.
Measured: MAX 2 Years
Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
The following adverse events were defined as items for priority investigation : (1) lung disorder including interstitial pneumonia, (2) bone marrow depression including platelets decreased, white blood cell decreased, and anaemia, (3) haemorrhage including those due to tumor degeneration or shrinkage, (4) cardiac function disturbance including QT interval prolonged and left ventricular ejection fraction decreased, (5) dysfunction adrenal, (6) pancreatic dysfunction including lipase increased, (7) thyroid function decreased, (8) cutaneous symptoms (hand and foot syndrome), (9) serious infections, (10) rhabdomyolysis, myopathy, and (11) reversible posterior leukoencephalopathy syndrome (RPLS). Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Measured: MAX 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716820
- Sponsor's protocol ID
- A6181175
- Status last verified
- Apr 2023
- First submitted
- 15 Jul 2008
- Last updated
- 6 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Survey Of Specific Use Of 12.5 Mg Sutent Capsule Against Gastrointestinal Stromal Tumor: Implementation Guidelines.
- ClinicalTrials.gov ID
- NCT00716820
- Acronym / sponsor ID
- A6181175
- Conditions
- Gastrointestinal Stromal Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2008 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 21 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first SUNITINIB MALATE(Sutent) should be registered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUNITINIB MALATE | – | Drug: SUNITINIB MALATEPatients taking Sutent. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A6181175 prescribes the SUNITINIB MALATE(Sutent).
Key inclusion criteria (1 listed)
- Patients need to be administered SUNITINIB MALATE(Sutent) in order to be enrolled in the surveillance.
Key exclusion criteria (1 listed)
- Patients not administered SUNITINIB MALATE(Sutent).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SUNITINIB MALATEAlso: SUTENTSUTENT capsule 12.5 mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "The usual adult dosage for oral sunitinib is 50 mg once daily, 4 weeks on followed by 2 weeks off (Schedule 4/2). This comprises 1 treatment cycle, which may be repeated. The dosage may be decreased according to the patient's clinical condition." | Drug | SUNITINIB MALATE |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: MAX 2 Years
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Objective Response Rate
Time frame: MAX 2 Years
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
9 secondary outcomes
Objective Response Rates by KIT Expression Status
Time frame: MAX 2 Years
Objective Response Rates by c-Kit Mutation Status
Time frame: MAX 2 Years
Objective Response Rates by Platelet - Derived Growth Factor Receptor Alpha (PDGFRα) Mutation Status
Time frame: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events in Elderly Population
Time frame: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
Time frame: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
Time frame: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
Time frame: MAX 2 Years
Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
Time frame: MAX 2 Years
Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
Time frame: MAX 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Related Adverse Events (time frame: MAX 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.