Clinical trial NCT01367457: INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus
Official title: Inhibitor - Estudio Retrospectivo De Casos Clinicos De Pacientes Con Carcinoma De Celulas Renales Y Con Linforma De Celulas Del Manto Tratados Con Temsirolimus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Lymphoma, Mantle-Cell
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.

Brief summary: The principal objective of the study is to evaluate the efficacy and safety of temsirolimus use in patients with Renal Cell Carcinoma and Mantle Cell Lymphoma.

Detailed description: There is not sampling method

Eligibility criteria: Inclusion Criteria:

Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.

Exclusion Criteria:

Patients that do not have a minimum (pre-specified) of data in their clinical record.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From initiation of treatment up to disease progression (up to 80 months)
measure: Percentage of Participants With Objective Response
timeFrame: From initiation of treatment up to disease progression (up to 80 months)
measure: Duration of Response (DOR)
timeFrame: From initiation of treatment up to disease progression (up to 80 months)
measure: Overall Survival (OS)
timeFrame: From initiation of treatment untill death (up to 80 months)
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Cabueñes
country: Spain
facility: Hospital de Cabueñes
state: Gijon
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario
state: La Coruña
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Materno-Infantil Insular de Las Palmas
state: Las Palmas
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Castellon
country: Spain
facility: Hospital Provincial de Castellon
state: Valencia
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Avila
country: Spain
facility: Complejo AAsistencial de Avilla
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital del Mar
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital de Madrid Norte - Sanchinarro
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: