Last updated: 11/07/2018 06:56:54

Non-PAZ RCC Chart Study in US, EU and Asia-Pacific

GSK study ID
113839
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Angiogenesis Inhibitor Therapies for Advanced Renal Cell Carcinoma: Toxicity and Treatment Patterns in Clinical Practice from a Global Medical Chart Review Study
Trial description: The goal of this retrospective medical records chart review study is to assess the real-world treatment patterns, safety, efficacy, and costs of anti-angiogenesis agents in patients with advanced renal cell carcinoma (RCC) over the course of angiogenesis inhibitor treatment. No treatment interventions are given as part of this study. Medical records of patients with RCC who received sorafenib, sunitinib, temsirolimus, or bevacizumab will be reviewed and relevant information abstracted. Data abstracted include prescriptions/administration of angiogenesis inhibitors and other anti-cancer agents, tumor response, diagnoses/identification of key adverse events (e.g., diarrhea, fatigue, hypertension, hypothyroidism, hand-foot syndrome), medical resource utilization, and socio-demographic factors (e.g., race, age, gender, insurance type). Chart reviews will be conducted in the US, Italy, France, Spain, Ireland, UK, Taiwan, Korea and Denmark. The observation period for each patient extends from initiation of a patient’s first angiogenesis inhibitor to the earliest of death, loss to follow-up, or end of the study period. Treatment patterns endpoints include rates of dose changes and interruptions, rates of discontinuations, and switching among agents, and reasons for these treatment modifications. Efficacy endpoints include ORR, PFS and OS. Safety endpoints include the proportion of patients experiencing key adverse events. Costs are modeled based on medical resource utilization.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Treatment patterns

Timeframe: Medical records were retrospectively reviewed at oncology centers in several countries from January 1st 2005

Secondary outcomes:
Not applicable
Interventions:
  • Drug: anti-angiogenesis treatment
  • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Castellano Guana D, Duh MS, et al. Safety and Treatment Patterns of Angiogenesis Inhibitors in Patients with Advanced Renal Cell Carcinoma in Spain. Expert Op Drug Safety. 2013;12(4):455-463.
    Oh WK, McDermott D, Porta C, et al. Angiogenesis Inhibitor Therapies for Advanced Renal Cell Carcinoma: Toxicity and Treatment Patterns in Clinical Practice from a Global Medical Chart Review . Int J Oncol. 2014;44:5-16.
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to April 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • received treatment at a participating center in US, Italy, France, Spain, Ireland, UK, Taiwan, Korea and Denmark
    • diagnosis of Renal Cell Carcinoma (RCC)
    • diagnosis of ...

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-02-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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