Carcinoma, Renal CellPhase 2CATChEzNCT01545817
Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma
A Phase 2 study testing Pazopanib followed by everolimus in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Pazopanib followed by everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 19 Apr 2012to 18 Nov 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Australia11 sites
Novartis Investigative Site
Auchenflower, Queensland, 4066
Novartis Investigative Site
Elizabeth Vale, South Australia, 5112
Novartis Investigative Site
Footscay, Victoria, 3011
Novartis Investigative Site
Frankston, Victoria, 3199
Novartis Investigative Site
Garran, Australian Capital Territory, 2606
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Kurralta Park, South Australia, 5037
Novartis Investigative Site
Nedlands, Western Australia, 6009
Novartis Investigative Site
Perth, Western Australia, 6001
Novartis Investigative Site
Southport, Queensland, 4215
Novartis Investigative Site
Woodville, South Australia, 5011
South Korea4 sites
Novartis Investigative Site
Gyeonggi-do, 10408
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 135-710
Novartis Investigative Site
Seoul, 138-736
About this study
Official title: Continuous Access to Advanced and Metastatic Renal Cell Carcinoma Therapy With Everolimus Post Pazopanib Treatment
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.
Read the 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.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Pazopanib followed by everolimus
- Keywords
- Renal cell carcinoma (RCC), GW786034, Everolimus, Pazopanib, renal cancer, cancer, kidney cancer, hypernephroma, Grawitz tumor, renal adenocarcinoma.
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pazopanib followed by everolimusDrug
Also called Pazopanib 1st line followed by everolimus 2nd line
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)
| Study group | Role | What they receive |
|---|---|---|
| Pazopanib followed by everolimus | Experimental | First line pazopanib, followed by second line everolimus Receives: Drug: Pazopanib followed by everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib.
Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs).
Measured: Throughout the study period, up to 4 years
Secondary outcomes (6)
Progression Free Survival (PFS) Rates
PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment.
Measured: 3 months, 6 months
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Percentage of patients with Complete or Partial Response at any time following the start of second-line everolimus treatment as per RECIST.
RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Measured: Throughout the study, up to 4 years
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Percentage of patients with Complete or Partial Response at any time following the start of first-line pazopanib treatment.
RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs.
Measured: Throughout the study period, up to 4 years
Overall Survival of Everolimus (OSE)
Time from first everolimus dose until death due to any cause
Measured: Throughout the study period, up to 4 years
Overall Survival From the Start (OSS) of Study Treatment
Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus
Measured: Throughout the study, up to 4 years
PFS for the Pazopanib Treatment Period Using RECIST
Time from first pazopanib dose until disease progression or death from any cause (whichever occurred earlier), provided this occurred prior to the start of everolimus and within 6 months of last dose of pazopanib
Measured: Throughout the study period, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study start19 Apr 2012
- Primary completion18 Nov 2016
- Study completion18 Nov 2016
Why it stopped: As the therapeutic landscape in renal cell carcinoma is changing, it has become apparent that information gained so far by CATChEz study is sufficient.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545817
- Sponsor's protocol ID
- 114907
- Acronym
- CATChEz
- Status last verified
- Sep 2019
- First submitted
- 17 Nov 2011
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Access to Advanced and Metastatic Renal Cell Carcinoma Therapy With Everolimus Post Pazopanib Treatment
- ClinicalTrials.gov ID
- NCT01545817
- Acronym / sponsor ID
- CATChEz / 114907
- Conditions
- Carcinoma, Renal Cell
- Keywords
- Renal cell carcinoma (RCC), GW786034, Everolimus, Pazopanib, renal cancer, cancer, kidney cancer, hypernephroma, Grawitz tumor, renal adenocarcinoma.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As the therapeutic landscape in renal cell carcinoma is changing, it has become apparent that information gained so far by CATChEz study is sufficient.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2012 (actual)
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 18 Nov 2016 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pazopanib followed by everolimus | Experimental | Drug: Pazopanib followed by everolimusFirst line pazopanib, followed by second line everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pazopanib followed by everolimusAlso: Pazopanib 1st line followed by everolimus 2nd lineAll patients received Pazopanib (800 mg once daily orally continuous dosing) until disease progression then second line everolimus (10 mg once daily orally continuous dosing) | Drug | Pazopanib followed by everolimus |
Primary outcome
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
Time frame: Throughout the study period, up to 4 years
Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib. Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs).
6 secondary outcomes
Progression Free Survival (PFS) Rates
Time frame: 3 months, 6 months
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Time frame: Throughout the study, up to 4 years
Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST
Time frame: Throughout the study period, up to 4 years
Overall Survival of Everolimus (OSE)
Time frame: Throughout the study period, up to 4 years
Overall Survival From the Start (OSS) of Study Treatment
Time frame: Throughout the study, up to 4 years
PFS for the Pazopanib Treatment Period Using RECIST
Time frame: Throughout the study period, up to 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib followed by everolimus in people with Carcinoma, Renal Cell, run by Novartis Pharmaceuticals at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST (time frame: Throughout the study period, up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.