- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073644
Post Marketing Surveillance On The Safety And Tolerability Of Sunitinib Malate (Sutent) For Filipino Patients
July 3, 2013 updated by: Pfizer
The primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Open label
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cebu City, Philippines
- Chong Hua Hospital
-
Manila, Philippines
- Private Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Study population will be selected by primary care clinic.
Description
Inclusion Criteria:
- Age 18 years and above
- Diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance
Exclusion Criteria:
- Subjects with conditions that are contraindicated with sunitinib malate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sunitinb malate
|
sunitinib 50 mg, 4 weeks on, 2 weeks off
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of sunitinib malate as measured by the incidence, severity, seriousness and relatedness to treatment adverse events (AEs), laboratory abnormalities, vital signs (blood pressure) and the use of concomitant medications.
Time Frame: 36 weeks
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness of sunitinib malate will be measured by the overall response as determined by the objective tumor assessments made according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Time Frame: 36 weeks
|
36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
February 22, 2010
First Submitted That Met QC Criteria
February 22, 2010
First Posted (Estimate)
February 23, 2010
Study Record Updates
Last Update Posted (Estimate)
July 4, 2013
Last Update Submitted That Met QC Criteria
July 3, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- 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
- A6181118
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.
Clinical Trials on Metastatic Renal Cell Carcinoma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
NewLink Genetics CorporationCompletedMetastatic Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Metastatic Kidney Cancer | Refractory Renal Cell Carcinoma | Metastatic Clear-cell Renal CancerUnited States
-
iOMEDICO AGNovartis PharmaceuticalsCompletedCarcinoma, Renal Cell | Clear-cell Metastatic Renal Cell Carcinoma | Locally Advanced and/or Metastatic Renal Cell CarcinomaGermany
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Roswell Park Cancer InstituteIovance Biotherapeutics, Inc.WithdrawnMetastatic Bladder Urothelial Carcinoma | Metastatic Renal Pelvis Urothelial Carcinoma | Metastatic Ureter Urothelial Carcinoma | Metastatic Urethral Urothelial Carcinoma | Unresectable Renal Pelvis Urothelial Carcinoma | Unresectable Ureter Urothelial CarcinomaUnited States
-
Centre Hospitalier Universitaire de Saint EtienneTerminatedMetastatic Renal Cell Carcinoma | Metastatic Kidney CancerFrance
-
National Cancer Institute (NCI)RecruitingStage IV Renal Cell Cancer AJCC v8 | Sarcomatoid Renal Cell Carcinoma | Stage IV Bladder Cancer AJCC v8 | Stage IV Urethral Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Bladder Adenocarcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Bladder... and other conditionsUnited States, Puerto Rico
-
Duke UniversityCompletedMetastatic Renal Cell Carcinoma | Metastatic Urothelial Carcinoma | Metastatic Castration-resistant Prostate Cancer (mCRPC)United States
-
Association Pour La Recherche des Thérapeutiques...CompletedClear-cell Metastatic Renal Cell Carcinoma | Clear-cell Renal CarcinomaFrance
-
Prometheus LaboratoriesCompletedMetastatic Renal Cell Carcinoma | Metastatic MelanomaUnited States
Clinical Trials on Sunitinib malate
-
PfizerCompletedGastrointestinal Stromal TumorsKorea, Republic of
-
PfizerCompletedGastrointestinal Stromal TumorsUnited States, Czechia, France
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedKidney CancerUnited States
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletedRenal Cell Carcinoma | Gastrointestinal Stromal Tumors | Pancreatic Neuroendocrine TumorChina
-
PfizerCompletedCarcinoma, Renal CellUnited States
-
Icahn School of Medicine at Mount SinaiPfizerCompleted
-
Sidney Kimmel Cancer Center at Thomas Jefferson...PfizerActive, not recruitingSunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal MelanomaCiliary Body and Choroid Melanoma, Medium/Large Size | Ciliary Body and Choroid Melanoma, Small Size | Iris Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage IIIC Intraocular Melanoma | Stage I Intraocular Melanoma | Stage IIA Intraocular Melanoma | Stage IIB Intraocular... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Metastatic Kidney CarcinomaUnited States
-
Tony Bekaii-SaabPfizerCompletedEsophageal CancerUnited States
-
California Pacific Medical Center Research InstitutePfizer; University of California, San FranciscoCompleted