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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01545817




Registration number
NCT01545817
Ethics application status
Date submitted
17/11/2011
Date registered
7/03/2012

Titles & IDs
Public title
Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma
Scientific title
Continuous Access to Advanced and Metastatic Renal Cell Carcinoma Therapy With Everolimus Post Pazopanib Treatment
Secondary ID [1] 0 0
114907
Universal Trial Number (UTN)
Trial acronym
CATChEz
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Renal Cell 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib followed by everolimus

Experimental: Pazopanib followed by everolimus - First line pazopanib, followed by second line everolimus


Treatment: Drugs: Pazopanib followed by everolimus
All patients received Pazopanib (800 mg once daily orally continuous dosing) until disease progression then second line everolimus (10 mg once daily orally continuous dosing)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
Timepoint [1] 0 0
Throughout the study period, up to 4 years
Secondary outcome [1] 0 0
Progression Free Survival (PFS) Rates
Timepoint [1] 0 0
3 months, 6 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Timepoint [2] 0 0
Throughout the study, up to 4 years
Secondary outcome [3] 0 0
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Timepoint [3] 0 0
Throughout the study period, up to 4 years
Secondary outcome [4] 0 0
Overall Survival of Everolimus (OSE)
Timepoint [4] 0 0
Throughout the study period, up to 4 years
Secondary outcome [5] 0 0
Overall Survival From the Start (OSS) of Study Treatment
Timepoint [5] 0 0
Throughout the study, up to 4 years
Secondary outcome [6] 0 0
PFS for the Pazopanib Treatment Period Using RECIST
Timepoint [6] 0 0
Throughout the study period, up to 4 years

Eligibility
Key inclusion criteria
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

Additional inclusion criteria for starting everolimus:

* Disease progression must be within 6 months after stopping pazopanib
* At least one measurable lesion at the start of everolimus pe r RECIST 1.1 criteria, as determined by CT or MRI
* In case of central nervous system (CNS) progression or metastasis during pazopanib treatment: asymptomatic or neurologically stable, no requirement of steroids to control CNS symptoms, and no requirement of enzyme-inducing anticonvulsants within 4 weeks prior to the start of everolimus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)
* History of cardiovascular disorders within the last 12 months (e.g. myocardial infraction or unstable angina), history of cerebrovascular events or pulmonary embolism within the last 6 months
* Active bleeding or bleeding susceptibility
* Known endobronchial lesion and/or lesions infiltrating major pulmonary vessels that increased the risk of pulmonary hemorrhage

Additional criteria for exclusion from the second-line everolimus treatment period:

- The subject felt by the investigator to be unsuitable (on the basis of health, compliance, or for any other reason) for inclusion in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/04/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/11/2016
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Auchenflower
Recruitment hospital [4] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [5] 0 0
Novartis Investigative Site - Elizabeth Vale
Recruitment hospital [6] 0 0
Novartis Investigative Site - Kurralta Park
Recruitment hospital [7] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [8] 0 0
Novartis Investigative Site - Footscay
Recruitment hospital [9] 0 0
Novartis Investigative Site - Frankston
Recruitment hospital [10] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [11] 0 0
Novartis Investigative Site - Perth
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [7] 0 0
5011 - Woodville
Recruitment postcode(s) [8] 0 0
3011 - Footscay
Recruitment postcode(s) [9] 0 0
3199 - Frankston
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
Korea, Republic of
State/province [1] 0 0
Gyeonggi-do
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01545817