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Trial record 1 of 1 for:    NCT01934452
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Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients (APERCU)

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ClinicalTrials.gov Identifier: NCT01934452
Recruitment Status : Recruiting
First Posted : September 4, 2013
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date August 2, 2013
First Posted Date September 4, 2013
Last Update Posted Date May 1, 2020
Actual Study Start Date May 21, 2015
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2013)
Characteristics of study patients [ Time Frame: Baseline up to 36 months ]
To compare characteristics of mRCC patients with CR versus mRCC patients without CR with Sutent, in order to identify factors associated with remission
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 29, 2013)
  • mRCC patients with CR [ Time Frame: Baseline up to 36 months ]
    To describe if mRCC patients with CR maintain or discontinue Sutent
  • Presence (rate) or Absence of blood biomarkers [ Time Frame: Baseline up to 36 months ]
    To identify biomarkers (FGF, IL8, VEGF...) of complete response and relapse/progression if occurs
  • Presence (rate) or Absence of blood biomarkers [ Time Frame: Baseline up to 36 months ]
    To compare the biomarkers previously identified between the 2 arms (patients with CR versus patients without CR)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Official Title ANALYSE PROSPECTIVE DES REMISSIONS COMPLETES OBSERVEES SOUS SUNITINIB CHEZ DES PATIENTS ATTEINTS D'UN CANCER DU REIN METASTATIQUE (MRCC)
Brief Summary

This prospective study will investigate the characteristics of mRCC patients at time of CR in comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some answers/ refection leads to the following questions :

Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify potential predictive serum biomarkers of recurrence? (With the aim of isolating blood biomarker that can help on treatment discontinuation decision?)

Detailed Description

The main objective of the study is to describe the characteristics of mRCC patients on CR with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR (controls) in order to identify factors associated with the occurrence of complete remission.

The results obtained on the sample must be representative of the population targeted by the study. The most appropriate method to obtain a representative sample is probability sampling.

A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the detection of a frequency difference between cases and controls corresponding to an OR of 0.24 for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of around 30% in control arm. The significance level was set at bilateral 5%.

The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina, United States).

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood and serum
Sampling Method Probability Sample
Study Population complete remission in mRCC patients treated with sunitinib versus non complete remission in mRCC patients treated with sunitinib
Condition Complete Remission in Renal Cell Carcinoma
Intervention
  • Drug: sunitinib
    50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
    Other Name: Cases
  • Drug: sunitinib
    50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
    Other Name: Controls
Study Groups/Cohorts
  • Complete Remission
    Complete remission arm in mRCC patients treated with sunitinib.
    Intervention: Drug: sunitinib
  • Non Complete Remission
    Non complete remission arm in mRCC patients treated with sunitinib.
    Intervention: Drug: sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 29, 2013)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with metastatic renal cell carcinoma, histopathologically confirmed
  • Treated with sunitinib according to Smpc
  • For cases: Achieving a CR (local assessment according to RECIST V1.0 criteria) with Sunitinib in prior 6 months alone OR in combination with local treatment (surgery, radiation therapy, ablative techniques: cryotherapy, RFA)
  • For controls: Life expectancy > 3 months No prior Sunitinib treatment
  • Patient >18 years

Exclusion Criteria:

  • Sunitinib administered in a non-approved label
  • For cases: CR occurring without sunitinib treatment
  • For controls: Prior systemic treatment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01934452
Other Study ID Numbers NRA6180080
A6181209 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2020