- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545817
Everolimus Post Pazopanib Treatment in Metastatic or Advanced Renal Cell Carcinoma (CATChEz)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Australia, 2606
- Novartis Investigative Site
-
-
New South Wales
-
Kogarah, New South Wales, Australia, 2217
- Novartis Investigative Site
-
-
Queensland
-
Auchenflower, Queensland, Australia, 4066
- Novartis Investigative Site
-
Southport, Queensland, Australia, 4215
- Novartis Investigative Site
-
-
South Australia
-
Elizabeth Vale, South Australia, Australia, 5112
- Novartis Investigative Site
-
Kurralta Park, South Australia, Australia, 5037
- Novartis Investigative Site
-
Woodville, South Australia, Australia, 5011
- Novartis Investigative Site
-
-
Victoria
-
Footscay, Victoria, Australia, 3011
- Novartis Investigative Site
-
Frankston, Victoria, Australia, 3199
- Novartis Investigative Site
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Novartis Investigative Site
-
Perth, Western Australia, Australia, 6001
- Novartis Investigative Site
-
-
-
-
-
Gyeonggi-do, Korea, Republic of, 10408
- Novartis Investigative Site
-
Seoul, Korea, Republic of, 03080
- Novartis Investigative Site
-
Seoul, Korea, Republic of, 138-736
- Novartis Investigative Site
-
Seoul, Korea, Republic of, 135-710
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pazopanib followed by everolimus
First line pazopanib, followed by second line 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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Throughout the study period, up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS) Rates
Time Frame: 3 months, 6 months
|
PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment.
|
3 months, 6 months
|
Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST
Time Frame: Throughout the study, up to 4 years
|
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. |
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
|
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. |
Throughout the study period, up to 4 years
|
Overall Survival of Everolimus (OSE)
Time Frame: Throughout the study period, up to 4 years
|
Time from first everolimus dose until death due to any cause
|
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
|
Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus
|
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
|
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
|
Throughout the study period, up to 4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Everolimus
Other Study ID Numbers
- 114907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Renal Cell
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Renal Cell Carcinoma | Metastatic Clear Cell Renal Cell Carcinoma | Advanced Clear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v8 | Stage IV Renal Cell Cancer AJCC v8 | Metastatic Sarcomatoid Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Unresectable Renal Cell... and other conditionsUnited States
-
Australian and New Zealand Urogenital and Prostate...RecruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11.2 Translocation-Related Renal Cell CarcinomaAustralia
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell CarcinomaUnited States
-
National Cancer Institute (NCI)Canadian Cancer Trials GroupActive, not recruitingUnresectable Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell Carcinoma | Metastatic Papillary Renal Cell Carcinoma | Locally Advanced Papillary Renal Cell CarcinomaUnited States, Canada
-
National Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Recurrent Renal Cell Carcinoma | Stage IV Renal Cell Cancer | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell CarcinomaUnited States, Taiwan, Australia
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingChromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma | Fumarate Hydratase Deficient Renal Cell Carcinoma | Succinate Dehydrogenase Deficient Renal Cell Carcinoma | Collecting Duct Renal...United States
-
Australian and New Zealand Urogenital and Prostate...Bristol-Myers SquibbActive, not recruitingRenal Cell Carcinoma | Sarcomatoid Renal Cell Carcinoma | Papillary Renal Cell Carcinoma Type 1 | Papillary Renal Cell Carcinoma Type 2 | Chromophobe Renal Cell Carcinoma | Xp11 Translocation CarcinomaAustralia
-
Bradley A. McGregor, MDBristol-Myers Squibb; ExelixisRecruitingRenal Cell Carcinoma | Chromophobe Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | Unclassified Renal Cell Carcinoma | Collecting Duct Renal Cell Carcinoma | Translocation Renal Cell Carcinoma | Unresectable Advanced Renal Cell Carcinoma | Metastatic Ncc Renal Cell CarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterBeiGene; Driven To CureWithdrawnMetastatic Renal Cell Carcinoma | Stage IV Renal Cell Cancer AJCC v8 | Papillary Renal Cell Carcinoma | Collecting Duct Carcinoma | Unresectable Renal Cell Carcinoma | Hereditary Leiomyomatosis and Renal Cell Carcinoma | Clear Cell Papillary Renal Neoplasm | Hereditary Papillary Renal Cell Carcinoma and other conditionsUnited States
-
Peloton Therapeutics, Inc.Active, not recruitingKidney Cancer | Renal Cell Carcinoma | Renal Cancer | Renal Cell Carcinoma (RCC) | Renal Cell Cancer Metastatic | Kidney | Clear Cell Renal Cell Carcinoma (ccRCC) | Renal Cell Carcinoma Recurrent | Renal Cell Cancer, RecurrentUnited States
Clinical Trials on Pazopanib followed by everolimus
-
Novartis PharmaceuticalsCompletedGastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic SystemGermany
-
Portuguese Oncology Institute, CoimbraCompletedColorectal Cancer | Recurrence, Local NeoplasmPortugal
-
American University of Beirut Medical CenterUnknownAnesthesia, RecoveryLebanon
-
Kraft Heinz CompanyBioFortisCompleted
-
Centre for Addiction and Mental HealthUniversity Health Network, TorontoCompletedMajor DepressionCanada
-
Hanmi Pharmaceutical Company LimitedCompletedDiabetes MellitusKorea, Republic of
-
Hartford HospitalRecruiting
-
Imperial College LondonCompletedIntermittent Pneumatic CompressionUnited Kingdom
-
University of Southern CaliforniaNot yet recruitingBinge-Eating Disorder
-
Eye & ENT Hospital of Fudan UniversityPeking University Third Hospital; Zhongshan Ophthalmic Center, Sun Yat-sen... and other collaboratorsRecruitingMalignant Tumor of Lacrimal Drainage StructureChina