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Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting (ADONIS)

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ClinicalTrials.gov Identifier: NCT02184416
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

Condition or disease Intervention/treatment
Metastatic Renal Cell Carcinoma (mRCC) Other: observational

Detailed Description:

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:

  • Sutent (prospective) - Inlyta
  • Sutent (retrospective) - Inlyta
  • Sutent - not further active treatment (supportive care)
  • Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. Therefore for some patients there will be a retrospective Sutent data collection. The primary endpoints of this study in patients with adv/mRCC are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Other
Time Perspective: Other
Official Title: AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)
Actual Study Start Date : October 31, 2014
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021


Group/Cohort Intervention/treatment
Observational Arm

Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be:

  • Sutent (prospective) - Inlyta
  • Sutent (retrospective) - Inlyta
  • Sutent - not further active treatment (supportive care)
  • Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other))
Other: observational
The study is non interventional. All drugs will be prescribed
Other Name: Nexavar (sorafenib), Votreint (pazopanib), Afinitor (everolimus), Torisel (temsirolimus)




Primary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    PFS for patients with adv/mRCC receiving Inlyta in 2nd line post Sutent is defined as the time from when the patient receives the first dose of Inlyta to the time of progression or death due to any cause, whichever occurs first

  2. Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    Combined PFS for patients with adv/mRCC receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line, until progression or death due to any cause with Inlyta in 2nd line, whichever occurs first during the Sutent-Inlyta sequence

  3. Time to Treatment Failure (TTF) [ Time Frame: 60 months ]
    TTF for Inlyta 2nd line is defined as from when the patient receives the first dose of Inlyta to the time of Inlyta discontinuation (date completed by the physician).

  4. Time to Treatment Failure (TTF) [ Time Frame: 60 months ]
    TTF for the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician).


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 60 months ]
    ORR for adv/mRCC patients receiving Inlyta in 2nd line post Sutent defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST criteria v1.1, relative to all patients who have baseline measurable disease.

  2. Overall Survival (OS) [ Time Frame: 60 months ]
    OS for adv/mRCC patients receiving Sutent in first line followed by Inlyta in 2nd line as measured from the date of first Sutent dose to the date of death of any cause.

  3. Time to strategy failure (TSF) [ Time Frame: 60 months ]
    TSF for patients receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician) without the time between discontinuation of Sutent and start of Inlyta.

  4. Dosing [ Time Frame: 60 months ]
    Description of real life usage of flexible dosing across Europe with description of treatment schedules (dosing change, dosing schedule, average dose received during the period treatment)

  5. Proportion of titrated patients [ Time Frame: 60 months ]
    A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.

  6. Progression-Free Survival (PFS) [ Time Frame: 60 months ]
    PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent

  7. Efficacy [ Time Frame: 60 months ]
    Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)

  8. Safety [ Time Frame: 60 months ]
    Safety description with AE listing in patients receiving Inlyta

  9. QoL [ Time Frame: 60 months ]
    QoL using the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaire and the Mental Health (MH) and Role-Emotional (RE) domains of the SF-36 questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment.
Criteria

Inclusion Criteria:

  • Patient 18 years of age and over
  • Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1
  • Patients being treated with Sutent in 1st line according to the European therapeutic indication and/or being treated with Inlyta in 2nd line according to the European approved therapeutic indication (except post cytokines)
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients being treated with cytokines or any other treatment outside of Sutent in 1st line
  • Patients receiving anti -tumor treatment beyond a second line
  • Patients already under Sutent, already under Inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184416


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02184416    
Other Study ID Numbers: A4061078
ADONIS ( Other Identifier: Alias Study Number )
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (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.
Keywords provided by Pfizer:
Inlyta
axitinib
Sutent
sunitinib
renal
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sorafenib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action