Continuous Access to Advanced and Metastatic Renal Cell Carcinoma Therapy With Everolimus Post Pazopanib Treatment
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
Pazopanib followed by everolimus
First line pazopanib, followed by second line everolimus
Intervention: Pazopanib followed by everolimus (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST(Throughout the study, up to 4 years)
- PFS for the Pazopanib Treatment Period Using RECIST(Throughout the study period, up to 4 years)
- Overall Survival of Everolimus (OSE)(Throughout the study period, up to 4 years)
- Progression Free Survival (PFS) Rates(3 months, 6 months)
- Overall Survival From the Start (OSS) of Study Treatment(Throughout the study, up to 4 years)
- Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST(Throughout the study period, up to 4 years)