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Comparison of Real-World Outcomes of 2nd Targeted Therapies in Patients with Metastatic Renal Cell Carcinoma (mRCC) a Multi-Country Retrospective Chart Review


- candidate number23386
- NTR NumberNTR5681
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2015
- Secondary IDs06-12-2014 
- Public TitleComparison of Real-World Outcomes of 2nd Targeted Therapies in Patients with Metastatic Renal Cell Carcinoma (mRCC) a Multi-Country Retrospective Chart Review
- Scientific TitleComparison of Real-World Outcomes of 2nd Targeted Therapies in Patients with Metastatic Renal Cell Carcinoma (mRCC) a Multi-Country Retrospective Chart Review
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedRenal cell cancer, Metastasis
- Inclusion criteria Adult patients (age ≥18 years, males and females) diagnosed with mRCC per medical chart

The patient received 1st targeted therapy with either sunitinib or pazopanib (i.e. a TKI other than sorafenib or axitinib)

The patient experienced disease progression during their 1st targeted therapy and subsequently initiated one of the following 2nd targeted therapies:
(1) Everolimus
(2) Sorafenib
(3) Axitinib

The date of initiating 2nd targeted therapy was during a defined time period from the time when everolimus, sorafenib, and axitinib all became available in the local market, to 20 months (tentative, pending on sample size) prior to the data extraction time

Treatment history and outcomes related to mRCC are available for chart review
- Exclusion criteria The patient used an mTOR inhibitor, bevacizumab or cytokines [IL-2, IFN- α2a] prior to initiation of the 2nd targeted therapy

The patient used a combination therapy with ≥2 targeted agents prior to or upon the initiation of the 2nd targeted therapy

The patient initiated the 2nd targeted therapy in an interventional trial in the mRCC setting
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 20-okt-2015
- planned closingdate15-dec-2015
- Target number of participants450
- InterventionsN/A as we are not assigning patients into a specific treatment group
- Primary outcomeCharacterize differences in the following outcomes in mRCC patients receiving 2nd targeted therapy with everolimus, sorafenib, or axitinib following a 1st targeted therapy with sunitinib or pazopanib:

a. OS from the initiation of 2nd targeted therapy
b. Treatment duration of the 2nd targeted therapy
c. PFS from the initiation of 2nd targeted therapy
- Secondary outcomeCharacterize differences in the primary outcomes within subgroups stratified by the following groups:
a. Type of 1st targeted therapy used
b. Long/short duration of 1st targeted therapy

Describe real-world treatment patterns:
a. Treatment duration of targeted therapies (by lines of treatment), and reasons for discontinuation
b. Dose, dose adjustment and underlying reasons for dose adjustment during 2nd targeted therapy; estimated total dose received for the 2nd-targeted therapy
c. Utilization and types of 3rd targeted therapies

Characterize differences in resource use following initiation of 2nd targeted therapy
- TimepointsN/A
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Dony Patel
- CONTACT for SCIENTIFIC QUERIES Dony Patel
- Sponsor/Initiator Novartis Pharma
- Funding
(Source(s) of Monetary or Material Support)
Novartis
- Publications
- Brief summaryRenal Cell Carcinoma (RCC) is a common adult malignancy worldwide. At RCC diagnosis, more than one fourth of patients present with metastatic disease, and about half of those with resectable disease eventually develop metastases. Tyrosine kinase inhibitors (TKIs) and inhibitors of the mammalian target of rapamycin (mTOR) are the current standard of care for patients with metastatic RCC (mRCC). To date, four TKIs (axitinib, sorafenib, sunitinib, and pazopanib) and two inhibitors of mTOR (temsirolimus and everolimus) have been approved for the treatment of mRCC in multiple countries, including the EU 5, Japan, Canada, and US.

TKIs can prolong overall and progression-free survival in patients with mRCC, and have been the most commonly used as 1st targeted therapy. However, almost all RCC patients eventually fail their 1st targeted therapy and experience progression. Maximizing the value of the mRCC therapeutic armamentarium will require careful selection of the next treatment. Given the growing number of treatment options, limited comparative evidence and lack of consensus on proper sequencing in mRCC, a well-conducted observational study of real-world outcomes of 2nd targeted therapy may provide valuable inputs for decision making. Commonly used 2nd targeted therapies include sorafenib, everolimus, axitinib, and temsirolimus (Market share data, Novartis data on file). In addition, an increased use of axitinib and a decreased use of temsirolimus have been observed (Market Share data on file). Thus, the current study proposes to evaluate the real-world use of everolimus, sorafenib and axitinib as 2nd targeted therapy.
- Main changes (audit trail)
- RECORD16-nov-2015 - 4-apr-2016


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