Carcinoma, Renal Cell Clinical Trial
Official title:
A Single Arm Multicentre Study Evaluating Pazopanib in First-line Treatment of Poor-risk Patients With Locally Advanced or Metastatic Renal Cell Carcinoma
Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial
Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate
and poor. To our knowledge there is only one study which examined the poor risk group (Hudes
et al.), which led to the approval of temsirolimus in this population. However temsirolimus
demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid
Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all
patients are suitable for temsirolimus treatment.
Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase
Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a
mTKI-treatment in high-risk patients has not been conducted.
Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma
in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib
group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was
performed. Therefore further data in this group of patients with high medical need is needed.
Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI
treatment. This is one of the most important scientific questions in this field. In addition
to the clinical endpoints in this study, the comprehensive biomarker program seeks to
evaluate biomarker candidates and will help to learn more about the effects of pazopanib on
the human organism.
n/a
| 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 |