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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00474786
Other study ID # 3066K1-404
Secondary ID B1771003
Status Completed
Phase Phase 3
First received May 15, 2007
Last updated October 28, 2013
Start date September 2007
Est. completion date January 2013

Study information

Verified date October 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sorafenib
Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
temsirolimus (Torisel)
Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  Chile,  China,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Singapore,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

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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