- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716625
Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment Plan)
Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered sunitinib malate (Sutent).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
sunitinib malate
Patients taking sunitinib malate
|
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."
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.).
|
MAX 2 Years
|
Objective Response Rate
Time Frame: MAX 2 Years
|
Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR.
The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
|
MAX 2 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Adverse Events in Elderly Population
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.).
Elderly population was defined as the participants who aged 65 or older.
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment
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.).
Hepatic impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment
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.).
Renal impairment referred not to transient laboratory test value abnormalities, but to the events that were clinically noteworthy and required follow-up.
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors
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.).
A total of 38 drugs including tofisopam, bromocriptin mesilate, and fluvoxamine maleate were defined as CYP3A4 inhibitors.
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment
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.).
The long-term treatment was defined as the treatment continued more than 24 weeks.
|
MAX 2 Years
|
Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation
Time Frame: MAX 2 Years
|
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.).
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events in Pediatric Population
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.).
Pediatric population was defined as the participants who aged younger than 15, and adult population was defined as those aged 15 or older.
|
MAX 2 Years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-Related Serious 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.
A treatmen-trelated serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
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.).
Expectedness of the adverse event was determined according to the Japanese package insert.
Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
|
MAX 2 Years
|
Number of Participants With Treatment-Related Adverse Events Grade 3 or Higher in Common Toxicity Criteria for Adverse Events (CTCAE)
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.).
The severity for each adverse event was assessed according to CTCAE as follows: grade 3, severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, or disabling; grade 4, life-threatening consequences or urgent intervention indicated; grade 5, death related to adverse event.
|
MAX 2 Years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- A6181176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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