Pazopanib in Second-line Therapy in Renal Cell Carcinoma
The principal aim of the study is to determine the objective response rate that offers the second-line treatment with pazopanib in patients with carcinoma of advanced renal cells that have progressed or that have not tolerated the first line of treatment with a Tyrosine Kinase Inhibitor. The secondary aims are to determine the overall survival and the treatment safety profile for these patients in second-line treatment with pazopanib. The exploratory aim is to determine the correlation between biomarkers in patient blood and tumor samples, and the clinical results obtained with pazopanib.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II, Opened, Not Controlled and Multicentric Clinical Trial of Pazopanib in Monotherapy to Determine Efficiency and Safety in Second-line of Treatment in Patients With Carcinoma of Advanced Renal Cells That Have Progressed or Have Not Tolerated the First Line of Treatment With Tyrosine Kinase Inhibitor|
- Objective Response Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
To asses the Objective Response (Complete Response or Partial Response) which provides second-line treatment with pazopanib in patients with carcinoma of advanced renal cell who have progressed or have not tolerated a first line of treatment with a Tyrosine Kinase Inhibitor.
The Objective Response Rate will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: No ]To assess the overall survival in patients treated with second-line treatment with pazopanib.
- Treatment Safety Profile [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
To assess the treatment safety profile in patients treated with second-line treatment with pazopanib.
Safety was assessed using Common Toxicity Criteria (CTC) of the National Cancer Institute (NCI), version 4.0.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
800 mg / day of pazopanib in monotherapy
800 mg / day of pazopanib in monotherapy.
Other Name: Pazopanib (GW786034; Votrient®)
Patients who progress or do not tolerate a first-line treatment with a Tyrosine Kinase Inhibitor will be included consecutively in the study. All patients will receive the same treatment regimen consisting of 800 mg / day of pazopanib in monotherapy.
All patients will receive treatment until there is evidence of progression, evidence of unacceptable toxicity, not compliance, investigator clinical decision or consent withdrawal by the patient.
After treatment, the patient will enter to the follow-up period. During this period the investigator will collect information from subsequent administered treatments and survival of all patients, regardless of the reason for withdrawal, every 8 weeks until the scheduled end of follow-up period, according to protocol. At 30 days after treatment completion, the first follow up visit will be scheduled to assess the possible occurrence of late toxicity. In those patients who complete treatment prior to objectify progression, information about the progression of the disease will be collected.
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33006|
|Hospital Universitari Son Espases|
|Palma de Mallorca, Baleares, Spain, 07010|
|Hospital Universitari Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospital de Bellvitge|
|Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Corporació Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital del Mar|
|Barcelona, Spain, 08003|
|Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28009|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital 12 de Octubre|
|Madrid, Spain, 28026|
|Study Chair:||Joaquim Bellmunt, MD||Hospital del Mar|
|Principal Investigator:||Marta Guix, MD||Hospital del Mar|
|Principal Investigator:||Juan Manuel Sepúlveda, MD||Hospital 12 de Octubre|
|Principal Investigator:||Enrique Gallardo, MD||Corporació Sanitaria Parc Taulí|
|Principal Investigator:||Xavier García del Muro, MD||Hospital Universitari de Bellvitge|
|Principal Investigator:||Olatz Etxaniz, MD||Hospital Universitari Germans Trias i Pujol|
|Principal Investigator:||José Luis González Larriba, MD||Hospital Clínico San Carlos|
|Principal Investigator:||Jose Angel Arranz, MD||Hospital General Universitario Gregorio Marañón|
|Principal Investigator:||Emilio Esteban, MD||Hospital Universitario Central de Asturias|
|Principal Investigator:||Aranzazu González del Alba, MD||HOSPITAL UNIVERSITARI SON ESPASES|
|Principal Investigator:||Pablo Maroto, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|