Last updated: 11/03/2018 17:23:00
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Continuous Access to advanced and metastatic renal cell Carcinoma therapy with Everolimus post pazopanib treatmentCATChEz
GSK study ID
114907
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Continuous Access to advanced and metastatic renal cell Carcinoma therapy with Everolimus post pazopanib treatment
Trial description: Study to determine the efficacy, safety and tolerability of first-line pazopanib followed by second-line everolimus in metastatic and advanced renal cell carcinoma
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
N\A
Primary outcomes:
Median progression free survival on everolimus
Timeframe: Everolimus treatment until earliest date of disease progression or death, assessed up to 30 months after the last patient has been enrolled
Secondary outcomes:
Median progression free survival of patients treated with pazopanib
Timeframe: Initiation of pazopanib until progression or death whichever comes first, provided this occurs prior to the commencement of everolimus and within 6 months of last dose of pazopanib, assessed up to 30 months after the last patient has been enrolled
Number of grade 3 or 4 adverse events attributable to everolimus
Timeframe: Time of first dose of everolimus to approximately one month after discontinuation of everolimus
Progression free survival proportion at three and six months after first everolimus dose
Timeframe: Initiation of everolimus treatment until earliest date of disease progression or death, assessed at three and six months after first everolimus dose
Overall survival for the study for patients receiving at least one dose of pazopanib followed by everolimus
Timeframe: Initiation of pazopanib until death for patients receiving at least one dose of pazopanib followed by everolimus, assessed up to 30 months after the last patient has been enrolled
Objective Response Rate to everolimus therapy
Timeframe: Initiation of everolimus treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled
All grade 3 or 4 adverse events attributable to pazopanib and everolimus treatments
Timeframe: Time of first dose of pazopanib to approximately one month after discontinuation of everolimus
Objective response rate to pazopanib therapy
Timeframe: Initiation of pazopanib treatment until time of confirmed best response, assessed up to 30 months after the last patient has been enrolled
Overall survival of patients treated with second-line everolimus therapy
Timeframe: Initiation of everolimus dose until death, assessed up to 30 months after the last patient has been enrolled
Interventions:
Drug: Pazopanib followed by everolimus
Enrollment:
70
Observational study model:
Not applicable
Primary completion date:
2016-01-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
April 2012 to April 2016
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 1. Written informed consent
- 2. Diagnosis of renal cell carcinoma with clear-cell component histology.
- 1. Pregnant/lactating
- 2. History of another malignancy (unless have been disease-free for 3 years)
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Written informed consent 2. Diagnosis of renal cell carcinoma with clear-cell component histology. 3. Locally advanced/metastatic renal cell carcinoma 4. Measurable lesion (RECIST 1.1) on physical exam or as CT/MRI 5. No prior systemic therapy for advanced/metastatic RCC 6. Karnofsky performance scale >=70 7. Age >=18 years 8. A female is eligible to enter and participate in this study if she is of: non-childbearing/agrees to use adequate contraception 9. A male with female partner of childbearing potential must have vasectomy/agree to use effective contraception from two weeks prior to administration of the 1st dose of study treatment for a period of time after the last dose of study treatment 10. Adequate organ function 11. Able to swallow and retain orally administered medication and must not have clinically significant GIT abnormalities that may alter absorption Additional criterion for inclusion in the everolimus treatment: 12. The date of disease progression must be within six months of stopping pazopanib or during treatment with pazopanib 13. Measurable lesion at Everolimus C1D1 Scan (everolimus baseline) as per the RECIST 1.1 criteria 14. Patients with radiotherapy prior to Everolimus treatment period will be eligible only if all below requirements are fulfilled: -The last radiotherapy fraction is delivered > 4 weeks prior to first dose of everolimus -The radiotherapy is not considered to be a second line treatment -The previously irradiated lesion(s) are not considered as target lesion(s) for everolimus RECIST 1.1 assessment -The radiotherapy field is not sufficiently close to the target lesion(s) so as to interfere with everolimus RECIST 1.1 assessments -There is no ongoing toxicity that is > Grade 1 and/or that is progressing in severity 16.Patients with central nervous system (CNS) progression or metastases during Pazopanib treatment period, will be eligible only if all below requirements are fulfilled: -Are asymptomatic and neurologically stable shown by no requirement for steroids (to control CNS symptoms) or enzyme-inducing anticonvulsants within 4 weeks prior to start of everolimus -If the lesion was previously been treated locally (by surgery ± radiotherapy, radiosurgery, or gamma knife) the last local treatment should be at least > 4 weeks prior to start of everolimus -Lesions that have been previously irradiated or in an area subjected to other loco‐regional therapy are not considered as target lesion(s) for everolimus RECIST 1.1 assessment -Have no presence of any non-healing wound
Exclusion criteria:
- 1. Pregnant/lactating 2. History of another malignancy (unless have been disease-free for 3 years) 3. History or clinical evidence of Central nervous system metastases (unless have previously-treated CNS metastases and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants in prior 6 month time interval. 4. Clinically significant gastrointestinal abnormalities including, but not limited to: malabsorption syndrome, major resection of the stomach or small bowel that could affect the absorption of study drug, active peptic ulcer disease, known intraluminal metastatic lesion/s with suspected bleeding, Inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess 5. Moderate to severe hepatic impairment (Child-Pugh Class C) 6. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with patient's safety, obtaining informed consent or compliance to the study. 7. Subjects receiving chronic treatment with corticosteroids/other immunosuppressive agents 8. Subjects with a known history of HIV seropositivity 9. Subjects with active bleeding, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin) 10. Presence of any severe or uncontrolled medical conditions/infection. 11. Currently receiving chemotherapy, immunotherapy or radiotherapy 12. Corrected QT interval (QTc) > 480 milliseconds 13. History of any one or more of the following cardiovascular conditions within the past 12 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery by-pass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association 14. Poorly controlled hypertension (defined as systolic blood pressure of >=140mmHg or diastolic blood pressure of >=90mmHg). 15. History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months (unless recent DVT have been treated with therapeutic anti-coagulating agents for at least 6 weeks) 16. Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer. 17. Evidence of active bleeding or bleeding susceptibility. 18. Known endobronchial lesion and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrage 19. Recent haemoptysis in excess of 2.5ml within eight weeks of first dose of study drug. 20. Use of an investigational agent, including an investigational anti-cancer agent, within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug. 21. Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. 22. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or everolimus, to other rapamycin derivatives or to any other excipients. Additional criterion for exclusion in the everolimus treatment: 23. The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, or for any other reason) for inclusion in the study. 24. Presence of any severe and/or uncontrolled medical conditions
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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