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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01367457
First received: June 3, 2011
Last updated: March 25, 2016
Last verified: March 2016
  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
Carcinoma, Renal Cell
Lymphoma, Mantle-Cell
Other: Temsirolimus (Non-Interventional Study)

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:
  • Progression-free Survival (PFS) [ Time Frame: From initiation of treatment up to disease progression (up to 80 months) ] [ Designated as safety issue: Yes ]
    Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.

  • Percentage of Participants With Objective Response [ Time Frame: From initiation of treatment up to disease progression (up to 80 months) ] [ Designated as safety issue: Yes ]
    Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)

  • Duration of Response (DOR) [ Time Frame: From initiation of treatment up to disease progression (up to 80 months) ] [ Designated as safety issue: Yes ]
    Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.

  • Overall Survival (OS) [ Time Frame: From initiation of treatment untill death (up to 80 months) ] [ Designated as safety issue: Yes ]
    Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.

  • Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to the 28 calendar days after the last administration of study drug (upto 80 months) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).


Enrollment: 243
Study Start Date: January 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (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   (Adult, Senior)
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 Vall D'Hebron
Barcelona, Spain, 08035
Hospital del Mar
Barcelona, Spain, 8940
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
La Coruña, Spain, 15006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
MD Anderson Cancer Center
Madrid, Spain, 28033
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital de Madrid Norte - Sanchinarro
Madrid, Spain, 28050
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01367457     History of Changes
Other Study ID Numbers: B1771017  INHIBITOR 
Study First Received: June 3, 2011
Results First Received: March 25, 2016
Last Updated: March 25, 2016
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on December 09, 2016