Carcinoma, Renal Cell Clinical Trial
Official title:
Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
This observational study is conducted as part of a systematic pharmacovigilance activity, to
provide a population-based context for Pazopanib use outside of the clinical trial setting.
The aims of the study are to examine the incidence of cardiovascular ischemia (including
myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular
accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients
treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN),
Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].
Two databases will be utilized for this study: a large healthcare claims database in the
U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large,
geographically varied, non-trial populations in which to examine the incidence of the stated
cardiovascular ischemic events and Torsades des Pointes.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02248389 -
Evaluation of a Laparoscopic High Intensity Focused Ultrasound Probe for the Ablation of Small Renal Masses
|
Phase 1 | |
| Completed |
NCT03900364 -
a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
|
N/A | |
| Completed |
NCT00158782 -
Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
|
Phase 1 | |
| Completed |
NCT03109015 -
Alternative Schedule Sunitinib in Metastatic Renal Cell Carcinoma: Cardiopulmonary Exercise Testing
|
Phase 2 | |
| Completed |
NCT00363194 -
A Two-way Crossover Study Of The Effect Of Food On The Pharmacokinetics Of Pazopanib In Cancer Patients
|
Phase 1 | |
| Completed |
NCT01012011 -
Regulatory Post Marketing Surveillance Study on Nexavar®
|
N/A | |
| Completed |
NCT00842790 -
Impact of Predicting Anti-angiogenic Response in mRCC Using Functional Imaging
|
N/A | |
| Completed |
NCT00529802 -
Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
|
Phase 2 | |
| Completed |
NCT00356460 -
Safety and Efficacy Study of GC1008 to Treat Renal Cell Carcinoma or Malignant Melanoma
|
Phase 1 | |
| Completed |
NCT00338884 -
Safety And Effectiveness Of Daily Dosing With 37.5 mg Sunitinib Malate In Patients With Advanced Kidney Cancer
|
Phase 2 | |
| Completed |
NCT00387764 -
Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
|
Phase 3 | |
| Completed |
NCT00095186 -
Safety/Efficacy Study of Oral Recombinant Human Lactoferrin in Renal Cell Carcinoma
|
Phase 2 | |
| Completed |
NCT00079612 -
Study of Nexavar (Sorafenib, BAY 43-9006) in Patients With Advanced Refractory Cancer
|
Phase 2 | |
| Completed |
NCT00043368 -
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
|
Phase 2 | |
| Active, not recruiting |
NCT04489771 -
A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
|
Phase 2 | |
| Completed |
NCT00516672 -
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT05104905 -
A Phase I/II Open Label Single Centre Trial to Assess the Safety, Tolerability and Efficacy of Single Dose Neoadjuvant Anti-CLEVER-1 Antibody Bexmarilimab in Localised Renal Cell and Colon Carcinoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT03685591 -
PF-06952229 Treatment in Adult Patients With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT03111901 -
Low-dose Interleukin-2 and Pembrolizumab in Melanoma and Renal Cell Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05544929 -
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
|
Phase 1 |