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INHIBITOR: Retrospective Study Of Patients With Renal Cell Carcinoma And Mantle Cell Lymphoma Treated With Temsirolimus

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01367457
First received: June 3, 2011
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
Lymphoma, Mantle-Cell
Other: Temsirolimus (Non-Interventional Study)
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients that received treatment with Temsirolimus
Patients with Renal Cell Carcinoma or Mantle Cell Lymphoma that have been treated with Temsirolimus as per clinical practice.
Other: Temsirolimus (Non-Interventional Study)
There is not any intervention in this study.

Detailed Description:

There is not sampling method

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367457

Locations
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital de Cabueñes
Cabueñes, Gijon, Spain, 33394
Hospital Clinico Universitario
Santiago de Compostela, La Coruña, Spain, 15706
Complejo Hospitalario Materno-Infantil Insular de Las Palmas
Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Provincial de Castellon
Castellon, Valencia, Spain, 12002
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Complejo AAsistencial de Avilla
Avila, Spain, 05004
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital del Mar
Barcelona, Spain, 8940
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
La Coruña, Spain, 15006
Hospital de Madrid Norte - Sanchinarro
Madrid, Spain, 28050
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
MD Anderson Cancer Center
Madrid, Spain, 28033
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01367457     History of Changes
Other Study ID Numbers: B1771017, INHIBITOR
Study First Received: June 3, 2011
Last Updated: October 30, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Lymphoma
Lymphoma, Mantle-Cell
Adenocarcinoma
Immune System Diseases
Immunoproliferative Disorders
Kidney Diseases
Kidney Neoplasms
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014