Renal Cell Carcinoma Clinical Trial
— INTORSECTOfficial title:
A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy
Verified date | October 2013 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
Status | Completed |
Enrollment | 512 |
Est. completion date | January 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously). - At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery. - At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions. - More criteria apply Exclusion Criteria: - Metastatic CNS from RCC. - Subjects who discontinued Sutent therapy due specifically to intolerance. - Prior systemic therapy for mRCC other than sunitinib. - Active ketonuria, secondary to poorly controlled diabetes mellitus - More criteria apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Pfizer Investigational Site | Buenos Aires | |
Argentina | Pfizer Investigational Site | Buenos Aires | |
Argentina | Pfizer Investigational Site | Buenos Aires | |
Argentina | Pfizer Investigational Site | Nueva Cordoba | |
Argentina | Pfizer Investigational Site | Rosario | Santa Fé |
Argentina | Pfizer Investigational Site | Tucuman | |
Australia | Pfizer Investigational Site | Adelaide | South Australia |
Australia | Pfizer Investigational Site | Elizabeth Vale | South Australia |
Australia | Pfizer Investigational Site | Kogarah | New South Wales |
Australia | Pfizer Investigational Site | South Brisbane | Queensland |
Australia | Pfizer Investigational Site | St Leonards | New South Wales |
Australia | Pfizer Investigational Site | Westmead | New South Wales |
Australia | Pfizer Investigational Site | Woodville South | South Australia |
Austria | Pfizer Investigational Site | Salzburg | |
Austria | Pfizer Investigational Site | Wien | |
Canada | Pfizer Investigational Site | Cornwall | Ontario |
Canada | Pfizer Investigational Site | Edmonton | Alberta |
Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
Canada | Pfizer Investigational Site | Halifax | Nova Scotia |
Canada | Pfizer Investigational Site | Hamilton | Ontario |
Canada | Pfizer Investigational Site | Kelowna | British Columbia |
Canada | Pfizer Investigational Site | London | Ontario |
Canada | Pfizer Investigational Site | London | Ontario |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Ottawa | Ontario |
Canada | Pfizer Investigational Site | Ottawa | Ontario |
Canada | Pfizer Investigational Site | Toronto | Ontario |
Canada | Pfizer Investigational Site | Toronto | Ontario |
Canada | Pfizer Investigational Site | Vancouver | British Columbia |
Canada | Pfizer Investigational Site | Victoria | British Columbia |
Chile | Pfizer Investigational Site | Providencia | Santiago |
China | Pfizer Investigational Site | Hong Kong | |
Denmark | Pfizer Investigational Site | Aarhus C | |
Denmark | Pfizer Investigational Site | Herlev | |
Finland | Pfizer Investigational Site | Tampere | |
Finland | Pfizer Investigational Site | Turku | |
France | Pfizer Investigational Site | Angers | |
France | Pfizer Investigational Site | Besancon | |
France | Pfizer Investigational Site | Bordeaux | |
France | Pfizer Investigational Site | Caen Cedex 05 | |
France | Pfizer Investigational Site | Clermont-Ferrand Cedex 1 | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Lille | |
France | Pfizer Investigational Site | Lyon Cedex 08 | |
France | Pfizer Investigational Site | Marseille Cedex 9 | |
France | Pfizer Investigational Site | Montpellier | Cedex 5 |
France | Pfizer Investigational Site | Paris Cedex 15 | |
France | Pfizer Investigational Site | Poitiers Cedex | |
France | Pfizer Investigational Site | Saint Herlain/Nantes Cedex | |
France | Pfizer Investigational Site | Strasbourg | |
France | Pfizer Investigational Site | Vandoeuvre Les Nancy | |
France | Pfizer Investigational Site | Villejuif Cedex | |
Germany | Pfizer Investigational Site | Berlin | |
Germany | Pfizer Investigational Site | Dresden | |
Germany | Pfizer Investigational Site | Heidelberg | |
Germany | Pfizer Investigational Site | Kassel | |
Germany | Pfizer Investigational Site | Luebeck | |
Germany | Pfizer Investigational Site | Muenchen | |
Germany | Pfizer Investigational Site | Neuss | |
Germany | Pfizer Investigational Site | Ulm | |
Hungary | Pfizer Investigational Site | Budapest | |
Italy | Pfizer Investigational Site | Chieti | |
Italy | Pfizer Investigational Site | Firenze | |
Italy | Pfizer Investigational Site | Napoli | |
Italy | Pfizer Investigational Site | Pavia | |
Italy | Pfizer Investigational Site | Roma | |
Italy | Pfizer Investigational Site | Roma | |
Italy | Pfizer Investigational Site | Roma | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Korea, Republic of | Pfizer Investigational Site | Seoul | |
Netherlands | Pfizer Investigational Site | Dordrecht | |
Netherlands | Pfizer Investigational Site | Leeuwarden | |
Netherlands | Pfizer Investigational Site | Zwolle | |
Singapore | Pfizer Investigational Site | Singapore | |
Spain | Pfizer Investigational Site | Badalona | Barcelona |
Spain | Pfizer Investigational Site | Barcelona | |
Spain | Pfizer Investigational Site | Madrid | |
Spain | Pfizer Investigational Site | Madrid | |
Spain | Pfizer Investigational Site | Oviedo | Asturias |
Spain | Pfizer Investigational Site | Sabadell | Barcelona |
Spain | Pfizer Investigational Site | Sevilla | |
Spain | Pfizer Investigational Site | Valencia | |
Sweden | Pfizer Investigational Site | Göteborg | |
Sweden | Pfizer Investigational Site | Lund | |
Sweden | Pfizer Investigational Site | Malmo | |
Switzerland | Pfizer Investigational Site | Basel | |
Switzerland | Pfizer Investigational Site | Basel | BS |
Switzerland | Pfizer Investigational Site | Bruderholz | |
Switzerland | Pfizer Investigational Site | Geneva | GE |
Switzerland | Pfizer Investigational Site | Kleinriehenstrasse 30 | Basel |
Switzerland | Pfizer Investigational Site | Luzern | |
Switzerland | Pfizer Investigational Site | Rheinstrasse 26 | |
United Kingdom | Pfizer Investigational Site | Birmingham | |
United Kingdom | Pfizer Investigational Site | Cambridge | Cambridgeshire |
United Kingdom | Pfizer Investigational Site | Edgbaston | Birmingham |
United Kingdom | Pfizer Investigational Site | London | |
United Kingdom | Pfizer Investigational Site | Manchester | |
United Kingdom | Pfizer Investigational Site | Newcastle upon Tyne | |
United Kingdom | Pfizer Investigational Site | Withington | Manchester |
United States | Pfizer Investigational Site | Austin | Texas |
United States | Pfizer Investigational Site | Baltimore | Maryland |
United States | Pfizer Investigational Site | Bethesda | Maryland |
United States | Pfizer Investigational Site | Cleveland | Ohio |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Duarte | California |
United States | Pfizer Investigational Site | La Jolla | California |
United States | Pfizer Investigational Site | La Jolla | California |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Louisville | Kentucky |
United States | Pfizer Investigational Site | Meriden | Connecticut |
United States | Pfizer Investigational Site | Metairie | Louisiana |
United States | Pfizer Investigational Site | Municie | Indiana |
United States | Pfizer Investigational Site | New York | New York |
United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
United States | Pfizer Investigational Site | Orange | California |
United States | Pfizer Investigational Site | Riverside | California |
United States | Pfizer Investigational Site | Salt Lake City | Utah |
United States | Pfizer Investigational Site | Salt Lake City | Utah |
United States | Pfizer Investigational Site | San Antonio | Texas |
United States | Pfizer Investigational Site | San Diego | California |
United States | Pfizer Investigational Site | Seattle | Washington |
United States | Pfizer Investigational Site | Tulsa | Oklahoma |
United States | Pfizer Investigational Site | Tupelo | Mississippi |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Argentina, Australia, Austria, Canada, Chile, China, Denmark, Finland, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to 24 months | Yes |
Primary | Progression-Free Survival (PFS) | Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first. | Baseline up to 24 Months | Yes |
Secondary | Progression Free Survival (PFS) by Investigator Assessment | Interval from date of randomization until documentation of PD by an investigator tumor assessment, symptomatic deterioration, or death for any reason whichever occurred first. | Baseline up to 24 Months | No |
Secondary | Percentage of Participants With Tumor Response | Percentage of participants with tumor response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST and evaluated by independent central review. CR/PR persisted on repeat imaging study at least 4 weeks after initial documentation of response. PR had at least 30 percent decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. | Baseline up to 24 Months | No |
Secondary | Overall Survival (OS) | Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact. | Baseline to date of death from any cause (up to 24 months) | No |
Secondary | Percentage of Participants With PFS Events at 12, 24 and 36 Weeks by Independent Assessment | PFS: Interval from date of randomization until documentation of PD by an independent tumor assessment according to RECIST or death for any reason whichever occurred first. PFS calculated as (Weeks)=(randomization date minus first dose date plus 1) divided by 7. | Weeks 12, 24, and 36 | No |
Secondary | Duration of Response (DR) | Duration of response as defined by the time from CR or PR (whichever status recorded first) until the date of death or PD was objectively documented. Median and its 95 percent confidence interval (95% CI) were estimated using Kaplan-Meier method. | Baseline up to 24 Months | No |
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