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Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma

Continuous Access to Advanced and Metastatic Renal Cell Carcinoma Therapy With Everolimus Post Pazopanib Treatment

NCT01545817•Novartis Pharmaceuticals

Summary

Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by second-line everolimus in metastatic and advanced renal cell carcinoma. Due to changes in the RCC treatment landscape, info gained is no longer clinically relevant to patients. Data collected is deemed sufficient to meet objective.

Detailed Description

A non-randomised, open label, single-arm phase II study to evaluate the efficacy and safety of 1st-line pazopanib followed by 2nd-line everolimus in patients with previously untreated advanced or metastatic renal cell carcinoma. Subjects received initial therapy with pazopanib followed, on progression, by 2nd-line therapy with everolimus. Study treatment - sequential treatment with pazopanib followed by everolimus - to continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \>=18 years
•Histologically confirmed RCC with a clear-cell component
•Locally advanced or metastatic RCC
•At least one measurable lesion per RECIST 1.1 criteria, as determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
•No systemic therapy for advanced or metastatic RCC prior to enrollment
•Karnofsky Performance Status (KPS) ≥70
•Adequate baseline organ function
•A female was eligible to enter and participate in this study if she was of: non-childbearing potential, or negative serum pregnancy test with agreement to use adequate contraception during the study
•A male with female partner of childbearing potential must have vasectomy/agree to use effective contraception from 2 weeks prior to administration of the 1st dose of study treatment for a period of time after the last dose of study treatment
•Able to swallow and retain orally administered medication and must not have clinically significant GI abnormalities that may alter absorption
+3 more criteria

Exclusion Criteria

•Lactating female
•History of another malignancy (exception: patients disease-free for ≥3 years and patients with completely resected non-melanoma skin cancer or successfully treated in situ carcinoma)
•Symptomatic CNS metastases at baseline
•Clinically significant gastrointestinal abnormalities
•Moderate to severe hepatic impairment (Child Pugh Class C)
•Receiving chronic treatment with corticosteroids/other immunosuppressive agents
•Active bleeding, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
•Corrected QT interval (QTc) \>480 msec using Bazett's formula
•Presence of any severe or uncontrolled medical conditions/infection
•Poorly controlled hypertension (defined as systolic blood pressure of \>=140mmHg or diastolic blood pressure of \>=90mmHg)
+5 more criteria

Locations (15)

Novartis Investigative Site

Garran, Australian Capital Territory, Australia

Novartis Investigative Site

Kogarah, New South Wales, Australia

Novartis Investigative Site

Auchenflower, Queensland, Australia

Novartis Investigative Site

Southport, Queensland, Australia

Novartis Investigative Site

Elizabeth Vale, South Australia, Australia

Novartis Investigative Site

Kurralta Park, South Australia, Australia

Novartis Investigative Site

Woodville, South Australia, Australia

Novartis Investigative Site

Footscay, Victoria, Australia

Novartis Investigative Site

Frankston, Victoria, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Key Dates

Start Date

April 19, 2012

Primary Completion Date

November 18, 2016

Completion Date

November 18, 2016

Last Updated

October 9, 2019

Enrollment

ACTUAL participants

Conditions

Carcinoma, Renal Cell

Interventions

Pazopanib followed by everolimus

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer

Autologous Dendritic Cell Vaccine in Kidney Cancer

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A Study of Combination Spartalizumab and Canakinumab in Patients With Localized Clear Cell Renal Cell Carcinoma

A Study of Atezolizumab in Combination With Cabozantinib Compared to Cabozantinib Alone in Participants With Advanced Renal Cell Carcinoma After Immune Checkpoint Inhibitor Treatment